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"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"--

Drug stability. --- Pharmaceutical industry. --- Drug industry --- Drug trade --- Medicine industry --- Medicines industry --- Prescription medicine industry --- Chemical industry --- Drugs --- Stability, Drug --- Pharmacology --- Stability

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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. .

Pharmacology. --- Pharmaceutical technology. --- Pharmacology/Toxicology. --- Pharmaceutical Sciences/Technology. --- Pharmaceutical laboratory techniques --- Pharmaceutical laboratory technology --- Technology, Pharmaceutical --- Technology --- Drug effects --- Medical pharmacology --- Medical sciences --- Chemicals --- Chemotherapy --- Drugs --- Pharmacy --- Physiological effect --- Drug stability. --- Stability, Drug --- Pharmacology --- Stability

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Pharmacotechnology. Preparations --- Drug stability --- Kinetics --- Médicaments --- Handbooks --- Stabilité --- Drug Stability. --- Kinetics. --- Drugs --- Stability, Drug --- Pharmacology --- Drug Stabilities --- Stabilities, Drug --- Stability --- Drug stability. --- Handbooks. --- Shelf Life, Drugs --- Drugs Shelf Life --- Drugs Shelf Lifes --- Life, Drugs Shelf --- Lifes, Drugs Shelf --- Shelf Lifes, Drugs --- Médicaments --- Stabilité --- Drug Stability --- Drug Shelf Life --- Shelf Life, Drug --- Drugs Shelf Lives --- Drugs Shelf Live --- Shelf Live, Drugs --- Shelf Lives, Drugs --- Analyse mathématique --- Mathematical analysis --- Cinetique chimique --- Stabilite

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A COMPREHENSIVE AND PRACTICAL GUIDE TO STABILITY TESTING IN PHARMACEUTICAL DEVELOPMENT Stability testing is required to demonstrate that a pharmaceutical product meets its acceptance criteria throughout its shelf life and to gain regulatory approval for commercialization. Assessing drug product stability and safety can be quite complicated, and stability profile can impact many functional areas, including analytical testing, formulation development, toxicology, quality, and regulatory affairs. Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices is the first volume to cover all aspects of stability testing in pharmaceutical development. It presents a scientific understanding of regulations and balances methodologies and best practices. Comprising 17 chapters, it provides a wealth of resources for pharmaceutical companies, educational institutions, and manufacturing laboratories to use as either a supplementary text for stability training courses or as a reference book for pharmaceutical practitioners. Topics covered include: Latest regulations for stability testing, including cGMP requirements, ICH guidelines, and global guidances from WHO, ASEAN, EMRO, and other regions. Post-approval considerations and regulatory filing strategies to support a global supply chain. Methodologies, including development of a stability-indicating method, method validation, and transfer. This book also discusses physical stability, non-chromatographic methodologies, and spectroscopic applications. Setting specifications, monitoring impurities, and establishing shelf-life of pharmaceutical products. Data management, including stability reports, CMC, and discussion of out-of-specification (OOS) and out-of-trend (OOT). USP-NF testing in support of stability. Current industry best practices on stability operation, validation, and calibration of stability chambers including considerations for photo-stability testing. Discussion of matrixing and bracketing to support reduced stability testing. Overview of stability programs for biologics and drug-in-devices pharmaceutical products. This collective work was written by a group of prominent international experts, who have been directly responsible for instituting industry best practices and establishing the current stability guidelines.

Drug development. --- Drug stability. --- Drugs --Testing. --- Drug stability --- Drugs --- Drug development --- Evaluation Studies as Topic --- Chemicals and Drugs --- Technology, Pharmaceutical --- Investigative Techniques --- Analytical, Diagnostic and Therapeutic Techniques and Equipment --- Drug Stability --- Pharmaceutical Preparations --- Drug Evaluation --- Health & Biological Sciences --- Pharmacy, Therapeutics, & Pharmacology --- Testing --- Pharmacology. --- Drug effects --- Medical pharmacology --- Stability, Drug --- Stability --- Medicine. --- Biomedicine. --- Pharmacology/Toxicology. --- Medical sciences --- Chemicals --- Chemotherapy --- Pharmacy --- Physiological effect --- Pharmacology --- Toxicology. --- Medicine --- Poisoning --- Poisons --- Toxicology

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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.

Drug stability. --- Drugs --- Dosage forms. --- Pharmacy. --- Toxicology. --- Biochemistry. --- Chemistry, Organic. --- Pharmacology/Toxicology. --- Biochemistry, general. --- Organic Chemistry. --- Pharmacology. --- Organic chemistry. --- Organic chemistry --- Chemistry --- Biological chemistry --- Chemical composition of organisms --- Organisms --- Physiological chemistry --- Biology --- Medical sciences --- Drug effects --- Medical pharmacology --- Chemicals --- Chemotherapy --- Pharmacy --- Medicine --- Materia medica --- Pharmacology --- Composition --- Physiological effect --- Stability, Drug --- Compounding, Drug --- Dosage forms of drugs --- Drug compounding --- Pharmaceutical compounding --- Pharmaceutical dosage forms --- Drug delivery systems --- Stability