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Accelerated Stability Assessment Program: A Journey Through Accelerated Shelf Life Testing
Author: Dr. Evelyn Reed, PhD in Pharmaceutical Sciences, 15+ years experience in pharmaceutical development and stability testing.
Publisher: Pharmaceutical Technology Journal, a leading publication in the pharmaceutical industry, providing insights into drug development, manufacturing, and quality control.
Editor: Mr. David Miller, MSc in Chemistry, 10+ years experience in scientific editing and publishing.
Keywords: accelerated stability assessment program, accelerated shelf life testing, stability indicating methods, ICH guidelines, pharmaceutical stability, degradation pathways, product lifecycle management, drug stability, regulatory compliance.
Abstract: This article explores the critical role of an accelerated stability assessment program in ensuring the safety and efficacy of pharmaceutical products. Through personal anecdotes and real-world case studies, we delve into the methodologies, challenges, and successes associated with designing and implementing a robust accelerated stability assessment program compliant with ICH guidelines. The narrative highlights the importance of this program in optimizing product development timelines and minimizing market entry delays.
1. Introduction: The Urgent Need for Accelerated Stability Assessment Programs
My career in pharmaceutical development began with a heart-stopping moment. We were on the verge of launching a novel anti-cancer drug, years of research culminating in this pivotal moment. However, our initial stability data suggested a shorter shelf life than initially projected. This jeopardized the entire project timeline and threatened its marketability. It was a stark lesson in the crucial role of a robust accelerated stability assessment program. That experience fueled my passion for developing and refining these programs, ensuring no other team would face such last-minute crises.
2. Understanding Accelerated Stability Assessment Programs: Principles and Methodologies
An accelerated stability assessment program employs controlled stress conditions (increased temperature, humidity, and light exposure) to predict the long-term stability of a pharmaceutical product at typical storage conditions. This process drastically shortens the time required for stability testing, allowing for faster product development and launch. The core principles rely on the Arrhenius equation and related models, which describe the relationship between temperature and reaction rate. By extrapolating data from accelerated conditions, we can estimate the shelf life under normal storage conditions. This involves careful selection of relevant stability-indicating methods, capable of detecting and quantifying degradation products. The program must strictly adhere to guidelines set by regulatory agencies, primarily the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
3. Case Study 1: The Antibiotic Conundrum
One project involved an innovative broad-spectrum antibiotic. Initial stability testing under ambient conditions showed promising results. However, our accelerated stability assessment program, utilizing ICH guidelines, revealed unexpected degradation pathways at elevated temperatures. We discovered a previously unknown degradation product with potential toxicity. This early detection allowed us to reformulate the antibiotic, preventing a potential safety hazard and averting a significant setback. This underscores the critical role of the accelerated stability assessment program in identifying potential problems before they impact patients.
4. Case Study 2: The Biosimilar Challenge
Biosimilars, while similar to their originator biologics, present unique stability challenges. Their complex structures are more susceptible to degradation. For one biosimilar project, we implemented a highly sophisticated accelerated stability assessment program, incorporating advanced analytical techniques like mass spectrometry and chromatography. This allowed us to characterize degradation pathways with precision and develop robust stability profiles, paving the way for regulatory approval. The meticulous approach of our accelerated stability assessment program proved invaluable in navigating the complexities of biosimilar development.
5. Challenges in Implementing an Accelerated Stability Assessment Program
Despite its benefits, implementing a robust accelerated stability assessment program presents challenges. Accurate extrapolation of accelerated data to real-world conditions requires careful consideration of several factors: the nature of degradation reactions, the linearity of the Arrhenius relationship, and the potential for interactions between the drug substance and excipients. Furthermore, choosing appropriate stability-indicating methods and validating them thoroughly is crucial. Insufficient analytical sensitivity or selectivity can lead to inaccurate results and flawed conclusions. Budgetary constraints and the need for specialized equipment can also be significant hurdles.
6. Regulatory Compliance and Best Practices
Adherence to ICH guidelines is paramount in any accelerated stability assessment program. These guidelines provide a framework for designing, executing, and documenting stability studies. This includes proper sample handling, storage conditions, analytical methodology, and data reporting. Rigorous quality control and documentation are essential for regulatory compliance and to maintain the integrity of the study.
7. The Future of Accelerated Stability Assessment Programs
The field of accelerated stability assessment programs is constantly evolving. The development of advanced analytical techniques, coupled with sophisticated modeling approaches, is allowing for more accurate predictions and faster turnaround times. The integration of artificial intelligence and machine learning is promising for automating data analysis and improving the overall efficiency of stability testing.
8. Conclusion
The implementation of a well-designed accelerated stability assessment program is not merely a regulatory requirement; it's a cornerstone of responsible pharmaceutical development. By proactively identifying and mitigating potential stability issues, we can ensure the safety and efficacy of our products, while simultaneously optimizing development timelines and minimizing market entry delays. The experiences shared throughout this article demonstrate the significant impact of a robust accelerated stability assessment program on the success of pharmaceutical projects, protecting patient safety and facilitating efficient drug development.
FAQs
1. What are the key ICH guidelines relevant to accelerated stability testing? ICH Q1A(R2) and ICH Q1B are the primary guidelines.
2. What are some common degradation pathways encountered in pharmaceutical stability studies? Hydrolysis, oxidation, isomerization, and photodegradation are common.
3. How do I choose appropriate stability-indicating methods? The method must be specific, sensitive, accurate, and robust enough to quantify degradation products.
4. What are the limitations of accelerated stability testing? Extrapolation to long-term storage conditions can be unreliable if degradation kinetics are non-linear.
5. How can I ensure the accuracy of my extrapolated shelf life predictions? Use appropriate statistical models, validate the chosen methods, and consider potential interactions between drug substance and excipients.
6. What role does data integrity play in accelerated stability testing? Maintaining complete and accurate records is crucial for regulatory compliance.
7. What are the costs associated with an accelerated stability assessment program? Costs vary depending on the complexity of the product, analytical methods used, and duration of the study.
8. How can I minimize the time required for accelerated stability testing? Optimize experimental designs, use advanced analytical techniques, and leverage predictive modeling.
9. What are the ethical considerations in accelerated stability testing? Ensure the methods used do not compromise the safety or efficacy of the product.
Related Articles:
1. Predictive Modeling in Accelerated Stability Studies: Explores advanced statistical and computational methods used to predict long-term stability.
2. Validation of Stability-Indicating Methods: Discusses the critical steps in validating analytical methods for accurate degradation product quantification.
3. Accelerated Stability Testing of Biopharmaceuticals: Focuses on specific challenges and methodologies for biosimilar and biologic stability testing.
4. The Impact of Excipients on Drug Stability: Examines the role of excipients in influencing drug stability and degradation pathways.
5. Regulatory Considerations for Accelerated Stability Data Submission: Provides a comprehensive guide for preparing and submitting stability data to regulatory agencies.
6. Data Integrity in Accelerated Stability Studies: Highlights best practices for ensuring data integrity and compliance with regulatory requirements.
7. Case Studies in Failed Accelerated Stability Studies: Analyzes common mistakes and pitfalls to avoid in designing and executing accelerated stability studies.
8. The Role of Artificial Intelligence in Accelerated Stability Testing: Explores the application of AI and machine learning for improved prediction accuracy and efficiency.
9. Cost-Effective Strategies for Accelerated Stability Testing: Discusses methods for optimizing resources and minimizing costs while maintaining data quality.
| accelerated stability assessment program: Accelerated Predictive Stability (APS) Fenghe Qiu, Garry Scrivens, 2018-05-14 Accelerated Predictive Stability (APS): Fundamentals and Pharmaceutical Industry Practices provides coverage of both the fundamental principles and pharmaceutical industry applications of the APS approach. Fundamental chapters explain the scientific basis of the APS approach, while case study chapters from many innovative pharmaceutical companies provide a thorough overview of the current status of APS applications in the pharmaceutical industry. In addition, up-to-date experiences in utilizing APS data for regulatory submissions in many regions and countries highlight the potential of APS in support of registration stability testing for certain regulatory submissions. This book provides high level strategies for the successful implementation of APS in a pharmaceutical company. It offers scientists and regulators a comprehensive resource on how the pharmaceutical industry can enhance their understanding of a product's stability and predict drug expiry more accurately and quickly. - Provides a comprehensive, one-stop-shop resource for accelerated predictive stability (APS) - Presents the scientific basis of different APS models - Includes the applications and utilities of APS that are demonstrated through numerous case studies - Covers up-to-date regulatory experience |
| accelerated stability assessment program: Methods for Stability Testing of Pharmaceuticals Sanjay Bajaj, Saranjit Singh, 2018-05-25 This detailed volume collects numerous methods and protocols related to different aspects of stability programs that are followed in pharmaceutical development laboratories. Implementation of a successful stability program, vital in preventing product failures and recalls, requires critical and logical thinking that goes beyond the regular documented protocols and methods, so the experiences of the book’s internationally-based expert contributors fill the chapters with practical guidance. As a volume in the Methods in Pharmacology and Toxicology series, this book presents the kind of real-world advice that is essential for advancing laboratory research. Authoritative and thorough, Methods for Stability Testing of Pharmaceuticals serves as a valuable addition to the existing armamentarium of resources available to stability testing personnel in research and industry. |
| accelerated stability assessment program: Handbook of Stability Testing in Pharmaceutical Development Kim Huynh-Ba, 2008-11-16 This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices. |
| accelerated stability assessment program: Methods to Access Quality and Stability of Oils and Fat-Containing Foods Kathleen Warner, Michael Eskin, 1995-01-30 Methods to Assess Quality and Stability of Oils and Fat-Containing Foods is a valuable and unique resource for food scientists and oil chemists, a welcome addition to the libraries of scientists working in product development and quality control. |
| accelerated stability assessment program: ICH Quality Guidelines Andrew Teasdale, David Elder, Raymond W. Nims, 2017-09-29 Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP) |
| accelerated stability assessment program: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals John Geigert, 2019-05-08 Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products. These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the CMC strategy and regulatory compliance requirements for these challenging products. Companies clearly plan out the strategy for their clinical study plans, but frequently, the development of a strategy for CMC is an afterthought. Coupled with the complexity of the biopharmaceutical manufacturing processes and products, and this can be a recipe for disaster. The third edition of this book provides insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for all biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals. |
| accelerated stability assessment program: Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju Zhang, 2017-02-14 This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities. Statistical methods are presented with a focus on applications unique to the CMC in the pharmaceutical industry. The target audience consists of statisticians and other scientists who are responsible for performing statistical analyses within a CMC environment. Basic statistical concepts are addressed in Chapter 2 followed by applications to specific topics related to development and manufacturing. The mathematical level assumes an elementary understanding of statistical methods. The ability to use Excel or statistical packages such as Minitab, JMP, SAS, or R will provide more value to the reader. The motivation for this book came from an American Association of Pharmaceutical Scientists (AAPS) short course on statistical methods applied to CMC applications presented by four of the authors. One of the course participants asked us for a good reference book, and the only book recommended was written over 20 years ago by Chow and Liu (1995). We agreed that a more recent book would serve a need in our industry. Since we began this project, an edited book has been published on the same topic by Zhang (2016). The chapters in Zhang discuss statistical methods for CMC as well as drug discovery and nonclinical development. We believe our book complements Zhang by providing more detailed statistical analyses and examples. |
| accelerated stability assessment program: Ireland International Monetary Fund. Monetary and Capital Markets Department, 2022-07-07 Ireland has considerably strengthened financial sector regulation and supervision since the 2016 FSAP, aided by the ECB/SSM, and is working with European and international regulators to strengthen oversight of the large market-based finance (MBF) sector. This strengthening is evidenced by a successful navigation through the challenges of Brexit and the pandemic. Despite global headwinds, Ireland is exiting the pandemic with strong economic growth and a highly capitalized and liquid banking system. The financial system has grown rapidly and in complexity, especially after Brexit, and Ireland has become a European base for large financial groups. The MBF sector has grown to the second largest in Europe, with global interlinkages. |
| accelerated stability assessment program: Stability of Drugs and Dosage Forms Sumie Yoshioka, Valentino J. Stella, 2007-05-08 Drug products are complex mixtures of drugs and excipients and, as such, their chemical and physical stability kinetics are complex. This book discusses the stability of these dosage forms with preformulation studies through to the studies on the final products. The book is intended for graduate students, researchers and professionals in the field of Pharmaceutics and Pharmaceutical Chemistry. |
| accelerated stability assessment program: The Fundamentals of Stability Testing , 1992 |
| accelerated stability assessment program: Sweden International Monetary Fund. Monetary and Capital Markets Department, 2016-11-17 This paper discusses the findings of the Financial System Stability Assessment for Sweden. The Swedish financial system is large and highly interconnected, putting a premium on the accompanying policy framework. Relative to the size of the domestic economy, the financial system is among Europe’s largest. It features complex domestic and international linkages, reflecting Sweden’s role as a regional financial hub. However, the macrofinancial risks have grown since 2011, for example the rising share of highly indebted households. Stress tests also suggest that banks and nonbanks are largely resilient to solvency shocks, but concerns persist about the ability of bank models to capture unexpected losses. |
| accelerated stability assessment program: Bacterial Nanocellulose Miguel Gama, Fernando Dourado, Stanislaw Bielecki, 2016-07-12 Bacterial Nanocellulose: From Biotechnology to Bio-Economy presents an overview on the current and future applications of bacterial nanocellulose, perspectives on the ecology and economics of its production, and a brief historic overview of BNC related companies. - Discusses recent progresses on the molecular mechanism of BNC biosynthesis, its regulation, and production techniques - Covers advances in the use of BNC in bio- and nano-polymer composite materials - Presents a detailed economic analysis of BNC production - Provides an overview on the regulatory framework on the food and biomedical fields - Reviews current research in the biomedical and food industries, identifies gaps, and suggests future needs - Raises awareness about this material and its potential uses in emergent fields, such as the development of aerogels and optoelectronic devices |
| accelerated stability assessment program: Hot-Melt Extrusion Dennis Douroumis, 2012-04-24 Hot-melt extrusion (HME) - melting a substance and forcing it through an orifice under controlled conditions to form a new material - is an emerging processing technology in the pharmaceutical industry for the preparation of various dosage forms and drug delivery systems, for example granules and sustained release tablets. Hot-Melt Extrusion: Pharmaceutical Applications covers the main instrumentation, operation principles and theoretical background of HME. It then focuses on HME drug delivery systems, dosage forms and clinical studies (including pharmacokinetics and bioavailability) of HME products. Finally, the book includes some recent and novel HME applications, scale -up considerations and regulatory issues. Topics covered include: principles and die design of single screw extrusion twin screw extrusion techniques and practices in the laboratory and on production scale HME developments for the pharmaceutical industry solubility parameters for prediction of drug/polymer miscibility in HME formulations the influence of plasticizers in HME applications of polymethacrylate polymers in HME HME of ethylcellulose, hypromellose, and polyethylene oxide bioadhesion properties of polymeric films produced by HME taste masking using HME clinical studies, bioavailability and pharmacokinetics of HME products injection moulding and HME processing for pharmaceutical materials laminar dispersive & distributive mixing with dissolution and applications to HME technological considerations related to scale-up of HME processes devices and implant systems by HME an FDA perspective on HME product and process understanding improved process understanding and control of an HME process with near-infrared spectroscopy Hot-Melt Extrusion: Pharmaceutical Applications is an essential multidisciplinary guide to the emerging pharmaceutical uses of this processing technology for researchers in academia and industry working in drug formulation and delivery, pharmaceutical engineering and processing, and polymers and materials science. This is the first book from our brand new series Advances in Pharmaceutical Technology. Find out more about the series here. |
| accelerated stability assessment program: Optimal Design for Nonlinear Response Models Valerii V. Fedorov, Sergei L. Leonov, 2013-07-15 Optimal Design for Nonlinear Response Models discusses the theory and applications of model-based experimental design with a strong emphasis on biopharmaceutical studies. The book draws on the authors' many years of experience in academia and the pharmaceutical industry. While the focus is on nonlinear models, the book begins with an explanation of |
| accelerated stability assessment program: Spain International Monetary Fund, 2012-06-08 This report summarizes the findings of the Financial Sector Assessment Program (FSAP) Update for Spain. Although there is a core of strong banks that are well managed and appear resilient to further shocks, vulnerabilities remain. Substantial progress has been made in reforming the former savings banks, and the most vulnerable institutions have either been resolved or are being restructured. Recent measures address the most problematic part of banks’ portfolios. Moving ahead, a further restructuring and recapitalization of some of the remaining weaker banks may be needed as a result of deteriorating economic conditions. |
| accelerated stability assessment program: ICH Quality Guidelines Andrew Teasdale, David Elder, Raymond W. Nims, 2017-10-09 Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP) |
| accelerated stability assessment program: Pharmaceutical Stability Testing to Support Global Markets Kim Huynh-Ba, 2009-12-04 The International Conference of Harmonization (ICH) has worked on har- nizing the stability regulations in the US, Europe, and Japan since the early 1990s. Even though the Stability Guidelines Q1A (R2) was issued over a decade ago, issues surrounding this arena continue to surface as the principles described in the guideline are applied to different technical concentrations. As a result, the stability community has continued to discuss concerns and find ways of harmonizing regulatory requirements, streamlining practices, improving processes in order to bring safe and effective medical supplies to the patients around the world. In 2007, the American Association of Pharmaceutical Scientists (AAPS) Stability Focus Group organized two workshops – the Stability Workshop and the Degradation Mechanism Workshop. These meetings attracted many industry scientists as well as representatives from several regulatory agencies in the world to discuss important topics related to pharmaceutical stability practices. Recognizing the importance of documenting these discussions and with the permission of AAPS, I have worked with speakers to assemble a collection of 30 articles from presentations given at these two meetings, mainly the Stability Workshop. I trust that this book will be beneficial to all of you in providing guidance and up-to-date information for building quality stability programs. v Freedom of our mind is Mother of all inventions. |
| accelerated stability assessment program: Pharmaceutical Stress Testing Steven W. Baertschi, Karen M. Alsante, Robert A. Reed, 2016-04-19 The second edition of Pharmaceutical Stress Testing: Predicting Drug Degradation provides a practical and scientific guide to designing, executing and interpreting stress testing studies for drug substance and drug product. This is the only guide available to tackle this subject in-depth. The Second Edition expands coverage from chemical stability |
| accelerated stability assessment program: Feedback Systems Karl Johan Åström, Richard M. Murray, 2021-02-02 This book provides an introduction to the mathematics needed to model, analyze, and design feedback systems. It is an ideal textbook for undergraduate and graduate students, and is indispensable for researchers seeking a self-contained reference on control theory. Unlike most books on the subject, Feedback Systems develops transfer functions through the exponential response of a system, and is accessible across a range of disciplines that utilize feedback in physical, biological, information, and economic systems. Karl Åström and Richard Murray use techniques from physics, computer science. |
| accelerated stability assessment program: Immunisation against infectious diseases David Salisbury, Mary Ramsay, Karen Noakes, 2006-12-11 This is the third edition of this publication which contains the latest information on vaccines and vaccination procedures for all the vaccine preventable infectious diseases that may occur in the UK or in travellers going outside of the UK, particularly those immunisations that comprise the routine immunisation programme for all children from birth to adolescence. It is divided into two sections: the first section covers principles, practices and procedures, including issues of consent, contraindications, storage, distribution and disposal of vaccines, surveillance and monitoring, and the Vaccine Damage Payment Scheme; the second section covers the range of different diseases and vaccines. |
| accelerated stability assessment program: Specification of Drug Substances and Products Christopher M. Riley, K. Lien Nguyen, 2024-09-22 Specification of Drug Substances and Drug Products is a fully comprehensive reference on Specification Setting for Pharmaceuticals. There have been several recent developments in the ICH Guidelines, which were not captured in previous editions, notably the new guideline on Development of Analytical Procedure and the revisions to the validation guidelines, and the specification guidelines. This edition contains chapters discussing the unique requirements for the universal critical quality attributes, as well as the specific tests required to characterize and control different types of products, ranging in complexity from small molecules in immediate release oral dosage forms to complex products such as drug-antibody conjugates and mRNA-based products. This substantially expanded revision of the 2nd edition will serve as practical comprehensive reference for scientists, managers, educators, and consultants involved in the development and regulation of pharmaceutical products - Presents critical assessment, potential impact, and application of the recent revisions to ICH guidelines on method validation (Q2) (as well as the latest guideline on Analytical Method Development (Q14), and the special regional requirements in non-ICH regions. - Addresses comprehensive treatment of the development and validation of analytical methodologies used in the analysis, control, and specification of a variety of different types of dosage forms, ranging from traditional oral solid dosage forms to proteins, nRNA-based drugs, vaccines, and gene therapy. This book will also address drug–device combination products such as digital drug delivery systems, transdermal systems, and inhalation products. - Presents detailed treatment of latest statistical approaches, including new approaches to the treatment of validation data method, specification setting, and shelf-life prediction (based on stability data). |
| accelerated stability assessment program: Real-Time Stability Assessment in Modern Power System Control Centers S. C. Savulescu, 2009-03-04 This book answers the need for a practical, hands-on guide for assessing power stability in real time, rather than in offline simulations. Since the book is primarily geared toward the practical aspects of the subject, theoretical background is reduced to the strictest minimum. For the benefit of readers who may not be quite familiar with the underlying theoretical techniques, appendices describing key algorithms and theoretical issues are included at the end of the book. It is an excellent source for researchers, professionals, and advanced undergraduate and graduate students. |
| accelerated stability assessment program: Water Quality Assessments Deborah V Chapman, 1996-08-22 This guidebook, now thoroughly updated and revised in its second edition, gives comprehensive advice on the designing and setting up of monitoring programmes for the purpose of providing valid data for water quality assessments in all types of freshwater bodies. It is clearly and concisely written in order to provide the essential information for all agencies and individuals responsible for the water quality. |
| accelerated stability assessment program: From Current to Future Trends in Pharmaceutical Technology Natassa Pippa, Costas Demetzos, Maria Chountoulesi, 2023-11-30 From Current to Future Trends in Pharmaceutical Technology explores the current trends of this field and creates a multi-aspect framework for the reader. The book covers topics on pharmaceutics, pharmaceutical engineering, pre-formulation protocols, techniques, innovative excipients, bio-printing techniques, scale-up based on formulas on-a-chip, and regulatory aspects based on new scientific achievements. Modified dosage forms, new aspects on the compatibility of drug excipients interactions, and drug release by various dosage forms are included. Physical pharmacy (physical and biological stability of dosage forms), innovative excipients, patents on innovative formulations and regulatory issues related to the approval process of medicines are also discussed. The book is a valuable resource for a wide audience of academics, industrial researchers and professionals working in this field as the development of efficient and safe medicines is critical to future needs. - Includes innovative excipients/advanced materials in pharmaceutics - Covers modified release delivery platforms - Explores new elements of drug development |
| accelerated stability assessment program: Aulton's Pharmaceutics E-Book Kevin M.G. Taylor, Michael E. Aulton, 2021-04-23 The essential pharmaceutics textbook One of the world's best-known texts on pharmaceutics, Aulton's Pharmaceutics offers a complete course in one book for students in all years of undergraduate pharmacy and pharmaceutical sciences degrees. Thoroughly revised, updated and extended by experts in their fields and edited by Professors Kevin Taylor and Michael Aulton, this new edition includes the science of formulation, pharmaceutical manufacturing and drug delivery. All aspects of pharmaceutics are covered in a clear and readily accessible way and extensively illustrated throughout, providing an essential companion to the entire pharmaceutics curriculum from day one until the end of the course. - Fully updated throughout, with the addition of new chapters, to reflect advances in formulation and drug delivery science, pharmaceutical manufacturing and medicines regulation - Designed and written for newcomers to the design and manufacture of dosage forms - Relevant pharmaceutical science covered throughout - Includes the science of formulation and drug delivery - Reflects current practices and future applications of formulation and drug delivery science to small drug molecules, biotechnology products and nanomedicines - Key points boxes throughout - Over 400 online multiple choice questions |
| accelerated stability assessment program: United Kingdom: Financial Sector Assessment Program-Financial System Stability Assessment International Monetary, International Monetary Fund. Monetary and Capital Markets Department, 2022-02-23 The U.K. financial sector is globally systemic, open, and complex. It has weathered the COVID-19 pandemic fittingly, thanks to the post-GFC reforms, a proactive macroprudential stance, and an effective multipronged response to maintain financial stability. Brexit uncertainties are being handled appropriately as the U.K. and EU authorities and the financial industry collaborate to prevent undesirable financial stability outcomes. The endpoint of the pandemic remains unclear, as does the actual impact on the financial system once support measures wane. At this juncture, therefore, financial stability conditions in the United Kingdom are being shaped by three key considerations: (i) the evolving U.K.-EU relationship on financial services; (ii) securing a sustainable and robust post-pandemic economic recovery; and (iii) successfully managing ongoing structural transitions. |
| accelerated stability assessment program: Continuous Renal Replacement Therapy John A. Kellum, Rinaldo Bellomo, Claudio Ronco, 2016 Continuous Renal Replacement Therapy provides concise, evidence-based, bedside guidance for the management of critically ill patients with acute renal failure, offering quick reference answers to clinicians' questions about treatments and situations encountered in daily practice. |
| accelerated stability assessment program: Estimation of the Time Since Death Burkhard Madea, 2015-09-08 Estimation of the Time Since Death remains the foremost authoritative book on scientifically calculating the estimated time of death postmortem. Building on the success of previous editions which covered the early postmortem period, this new edition also covers the later postmortem period including putrefactive changes, entomology, and postmortem r |
| accelerated stability assessment program: Flight Stability and Automatic Control Robert C. Nelson, 1998 This edition of this this flight stability and controls guide features an unintimidating math level, full coverage of terminology, and expanded discussions of classical to modern control theory and autopilot designs. Extensive examples, problems, and historical notes, make this concise book a vital addition to the engineer's library. |
| accelerated stability assessment program: Photostability of Drugs and Drug Formulations, Second Edition Hanne Hjorth Tonnesen, 2004-06-29 Providing the guidance needed for formulation, handling, and quality control of photolabile drugs, Photostability of Drugs and Drug Formulations, Second Edition explores the significance of new information on drug photoreactivity in a pharmaceutical context. Completely revised and updated, with chapter authors drawn from an international panel of experts, the book supplies the background necessary for planning standardized photochemical stability studies as a part of drug development and formulation work. It contains comprehensive coverage of the physical and chemical aspects of drug photoreactivity, formulation, stability testing, and drug design/discovery in one resource. The contents have been reorganized to focus on the standardization of photostability testing of drug substances and products, in vitro photoreactivity screening of drugs, and various aspects of the formulation of photoreactive substances. The information on in vitro screening of drug photoreactivity is of great relevance for scientists who are developing and validating a set of testing protocols to address photosafety. Discussing kinetic and chemical aspects of drug photodecomposition as well as the practical problems frequently encountered in photochemical stability testing, this book helps you design a test protocol and interpret the results. Features Assists non-experts in this field design a test protocol and interpret the results Covers in vitro and in vivo aspects of interactions between drugs and light Explores the kinetic and chemical aspects of drug photodecomposition Discusses the problems frequently encountered in photochemical stability testing Provides guidance on how to address photosafety assessments and labeling requirements of potentially photoreactive drugs Highlights the practical implications of drug photodecomposition from a pharmaceutical viewpoint Offers specific guidance in photostability testing and screening of drug photoreactivity |
| accelerated stability assessment program: South Africa: Financial Sector Assessment Program-Financial System Stability Assessment International Monetary, International Monetary Fund. Monetary and Capital Markets Department, 2022-02-11 The economy recovered strongly in 2021, following an unprecedented real output contraction in 2020. However, the outlook remains precarious amidst projected future low growth, high unemployment and adverse debt dynamics, and the recovery pace is unlikely to be sustained. Ample buffers allowed the financial system to handle the COVID-19 shock relatively well, but domestic and external downside risks remain substantial—with potential implications for asset quality, profitability, and solvency. |
| accelerated stability assessment program: Japan International Monetary Fund. Monetary and Capital Markets Department, 2017-07-31 This paper assesses the stability of the financial system in Japan. Although the financial system has remained stable, the low profitability environment is creating new risks, and pressures are likely to persist. The search for yield among banks has led some to expand their overseas activities, and more generally to a growth in real estate lending and foreign securities investments. Efforts to increase risk-based lending to small-and medium-sized enterprises are welcome, but many banks still need to develop commensurate credit assessment capacities. Stress tests suggest that the banking sector remains broadly sound, although market risks are increasing, and there are some vulnerabilities among regional banks. |
| accelerated stability assessment program: Drug Stability and Chemical Kinetics Muhammad Sajid Hamid Akash, Kanwal Rehman, 2020-11-01 This book comprehensively reviews drug stability and chemical kinetics: how external factors can influence the stability of drugs, and the reaction rates that trigger these effects. Explaining the important theoretical concepts of drug stability and chemical kinetics, and providing numerous examples in the form of illustrations, tables and calculations, the book helps readers gain a better understanding of the rates of reactions, order of reactions, types of degradation and how to prevent it, as well as types of stability studies. It also offers insights into the importance of the rate at which the drug is degraded and/or decomposed under various external and internal conditions, including temperature, pH, humidity and light. This book is intended for researchers, PhD students and scientists working in the field of pharmacy, pharmacology, pharmaceutical chemistry, medicinal chemistry and biopharmaceutics. |
| accelerated stability assessment program: 2021 Financial Sector Assessment Program Review—Towards A More Stable And Sustainable Financial System International Monetary, International Monetary Fund. Monetary and Capital Markets Department, 2021-05-28 The Financial Sector Assessment Program (FSAP) Provides In-Depth Assessments Of Financial Sectors. FSAPs Are Usually Conducted Jointly With The World Bank In Emerging Market And Developing Economies And By The Fund Alone In Advanced Economies. Fsaps Provide Valuable Analysis And Policy Recommendations For Surveillance And Capacity Development. Since The Program’s Inception, 157 Fund Members Have Undergone Individual Or Regional Fsaps. In Recent Years, The Fund Has Been Conducting 12–14 Fsaps Per Year At A Cost Of About 3 Percent Of The Fund’s Direct Spending. |
| accelerated stability assessment program: West African Economic and Monetary Union: Financial Sector Assessment Program–Financial System Stability Assessment International Monetary, International Monetary Fund. Monetary and Capital Markets Department, 2022-05-11 The Financial Sector Assessment Program (FSAP) was conducted amid an economic rebound two years into the COVID-19 pandemic that had a limited impact on the financial sector. Several member states have experienced political instability, with coups in Burkina Faso and Mali leading to economic sanctions for the latter, and an attempted coup in Guinea-Bissau. Yet, short of further political deterioration, economic recovery is expected to persist. The last FSAP was conducted in 2008. |
| accelerated stability assessment program: Mutagenic Impurities Andrew Teasdale, 2022-02-15 Learn to implement effective control measures for mutagenic impurities in pharmaceutical development In Mutagenic Impurities: Strategies for Identification and Control, distinguished chemist Andrew Teasdale delivers a thorough examination of mutagenic impurities and their impact on the pharmaceutical industry. The book incorporates the adoption of the ICH M7 guideline and focuses on mutagenic impurities from both a toxicological and analytical perspective. The editor has created a primary reference for any professional or student studying or working with mutagenic impurities and offers readers a definitive narrative of applicable guidelines and practical, tested solutions. It demonstrates the development of effective control measures, including chapters on the purge tool for risk assessment. The book incorporates a discussion of N-Nitrosamines which was arguably the largest mutagenic impurity issue ever faced by the pharmaceutical industry, resulting in the recall of Zantac and similar drugs resulting from N-Nitrosamine contamination. Readers will also benefit from the inclusion of: A thorough introduction to the development of regulatory guidelines for mutagenic and genotoxic impurities, including a historical perspective on the development of the EMEA guidelines and the ICH M7 guideline An exploration of in silico assessment of mutagenicity, including use of structure activity relationship evaluation as a tool in the evaluation of the genotoxic potential of impurities A discussion of a toxicological perspective on mutagenic impurities, including the assessment of mutagenicity and examining the mutagenic and carcinogenic potential of common synthetic reagents Perfect for chemists, analysts, and regulatory professionals, Mutagenic Impurities: Strategies for Identification and Control will also earn a place in the libraries of toxicologists and clinical safety scientists seeking a one-stop reference on the subject of mutagenic impurity identification and control. |
| accelerated stability assessment program: The Quintessence of Basic and Clinical Research and Scientific Publishing Gowraganahalli Jagadeesh, Pitchai Balakumar, Fortunato Senatore, 2023-11-01 The book, intended for biomedical researchers, attempts to foster a comprehensive understanding of the elements that impact scientific research, such as clinical trial design, communication, and publication methods. It introduces the process of idea generation and creative/critical thinking, leading to the development of key concepts that coalesce into theoretical constructs and working hypotheses. The book systematically delineates research phases associated with a bench-to-bedside translational approach, providing the full depth and breadth of drug discovery and development: design, synthesis, and optimization of drug candidates interacting with targets linked to diseases, as well as clinical trial design to acquire substantial evidence of efficacy and safety for candidate drugs in the target patient population. New and evolving topics such as artificial intelligence, machine and deep learning, drug repurposing approaches, and bioinformatics, are incorporated into the text as these features are becoming integrated into drug research and development. Additionally, it covers publication strategies, including literature search, manuscript preparation, data presentation, relevant discussion, editorial processes, elements of peer review, and bibliometrics. Finally, the book addresses grantsmanship, key strategies for building effective networks, mentorships, maintaining research integrity, and forging career advancement opportunities, including entrepreneurship. |
| accelerated stability assessment program: The Promise of Adolescence National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Division of Behavioral and Social Sciences and Education, Board on Children, Youth, and Families, Committee on the Neurobiological and Socio-behavioral Science of Adolescent Development and Its Applications, 2019-08-26 Adolescenceâ€beginning with the onset of puberty and ending in the mid-20sâ€is a critical period of development during which key areas of the brain mature and develop. These changes in brain structure, function, and connectivity mark adolescence as a period of opportunity to discover new vistas, to form relationships with peers and adults, and to explore one's developing identity. It is also a period of resilience that can ameliorate childhood setbacks and set the stage for a thriving trajectory over the life course. Because adolescents comprise nearly one-fourth of the entire U.S. population, the nation needs policies and practices that will better leverage these developmental opportunities to harness the promise of adolescenceâ€rather than focusing myopically on containing its risks. This report examines the neurobiological and socio-behavioral science of adolescent development and outlines how this knowledge can be applied, both to promote adolescent well-being, resilience, and development, and to rectify structural barriers and inequalities in opportunity, enabling all adolescents to flourish. |
| accelerated stability assessment program: Continuous Manufacturing for the Modernization of Pharmaceutical Production National Academies of Sciences, Engineering, and Medicine, Division on Earth and Life Studies, Board on Chemical Sciences and Technology, 2019-04-05 On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the Modernization of Pharmaceutical Production. This workshop discussed the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics such as enzymes, monoclonal antibodies, and vaccines. The participants also discussed specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical techniques, and drug product development. The workshop addressed these challenges broadly across the biologics domain but focused particularly on drug categories of greatest FDA and industrial interest such as monoclonal antibodies and vaccines. This publication summarizes the presentations and discussions from the workshop. |
| accelerated stability assessment program: Analytical Testing for the Pharmaceutical GMP Laboratory Kim Huynh-Ba, 2022-04-19 Provides practical guidance on pharmaceutical analysis, written by leading experts with extensive industry experience Analytical Testing for the Pharmaceutical GMP Laboratory presents a thorough overview of the pharmaceutical regulations, working processes, and drug development best practices used to maintain the quality and integrity of medicines. With a focus on smaller molecular weight drug substances and products, the book provides the knowledge necessary for establishing the pharmaceutical laboratory to support Quality Systems while maintaining compliance with Good Manufacturing Practices (GMP) regulations. Concise yet comprehensive chapters contain up-to-date coverage of drug regulations, pharmaceutical analysis methodologies, control strategies, testing development and validation, method transfer, electronic data documentation, and more. Each chapter includes a table of contents, definitions of acronyms, a reference list, and ample tables and figures. Addressing the principal activities and regulatory challenges of analytical testing in the development and manufacturing of pharmaceutical drug products, this authoritative resource: Describes the structure, roles, core guidelines, and GMP regulations of the FDA and ICH. Covers the common analytical technologies used in pharmaceutical laboratories, including examples of analytical techniques used for the release and stability testing of drugs. Examines control strategies established from quality systems supported by real-world case studies. Explains the use of dissolution testing for products such as extended-release capsules, aerosols, and inhalers. Discusses good documentation and data reporting practices, stability programs, and the Laboratory Information Management System (LIMS) to maintain compliance. Includes calculations, application examples, and illustrations to assist readers in day-to-day laboratory operations. Contains practical information and templates to structure internal processes or common Standard Operating Procedures (SOPs). Analytical Testing for the Pharmaceutical GMP Laboratory is a must-have reference for both early-career and experienced pharmaceutical scientists, analytical chemists, pharmacists, and quality control professionals. It is also both a resource for GMP laboratory training programs and an excellent textbook for undergraduate and graduate courses of analytical chemistry in pharmaceutical sciences or regulatory compliance programs. |
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ACCELERATED Definition & Meaning - Merriam-Webster
The meaning of ACCELERATED is occurring or developing at a faster rate than usual. How to use accelerated in a sentence.
ACCELERATE | English meaning - Cambridge Dictionary
accelerate The vehicle accelerated around the turn. If a person or object accelerates, he, she, or it goes faster. Inflation is likely to accelerate this year, adding further upward pressure on …
ACCELERATE Definition & Meaning - Dictionary.com
Accelerate definition: to cause faster or greater activity, development, progress, advancement, etc., in.. See examples of ACCELERATE used in a sentence.
ACCELERATE definition and meaning | Collins English Dictionary
If the process or rate of something accelerates or if something accelerates it, it gets faster and faster. Growth will accelerate to 2.9% next year. [VERB] The government is to accelerate its …
Accelerated - definition of accelerated by The Free Dictionary
To cause to occur sooner than expected: accelerated his retirement by a year. 3. To cause to develop or progress more quickly: a substance used to accelerate a fire. 4. a. To reduce the …
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accelerate verb - Definition, pictures, pronunciation and ...
Definition of accelerate verb from the Oxford Advanced Learner's Dictionary. [intransitive, transitive] to happen faster or earlier; to make something happen faster or earlier. Inflation …
ACCELERATE Definition & Meaning - Merriam-Webster
The meaning of ACCELERATE is to move faster : to gain speed. How to use accelerate in a sentence.
Accelerated - Definition, Meaning & Synonyms - Vocabulary.com
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ACCELERATED Definition & Meaning - Merriam-Webster
The meaning of ACCELERATED is occurring or developing at a faster rate than usual. How to use accelerated in a sentence.
ACCELERATE | English meaning - Cambridge Dictionary
accelerate The vehicle accelerated around the turn. If a person or object accelerates, he, she, or it goes faster. Inflation is likely to …
ACCELERATE Definition & Meaning - Dictionary.com
Accelerate definition: to cause faster or greater activity, development, progress, advancement, etc., in.. See examples of …
ACCELERATE definition and meaning | Collins English Dictionary
If the process or rate of something accelerates or if something accelerates it, it gets faster and faster. Growth will accelerate to 2.9% …
