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stability of drugs and dosage forms

stability of drugs and dosage forms



Sumie Yoshioka, Valentino J. Stella, "Stability of Drugs and Dosage Forms"
Springer; 1 edition (November 2000) ISBN: 0306464047 272 pages PDF 2,1 Mb

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.

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Statistical Design and Analysis of Stability Studies

Statistical Design and Analysis of Stability Studies

The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Pharmaceutical companies conduct stability studies to characterize the degradation of drug products and to estimate drug shelf life. Illustrating how stability studies play an important role in drug safety and quality assurance, Statistical Design and Analysis of Stability Studies presents the principles and methodologies in the design and analysis of stability studies. After introducing the basic concepts of stability testing, the book focuses on short-term stability studies and reviews several methods for estimating drug expiration dating periods. It then compares some commonly employed study designs and discusses both fixed and random batch statistical analyses. Following a chapter on the statistical methods for stability analysis under a linear mixed effects model, the book examines stability analyses with discrete responses, multiple components, and frozen drug products. In addition, the author provides statistical methods for dissolution testing and explores current issues and recent developments in stability studies. To ensure the safety of consumers, professionals in the field must carry out stability studies to determine the reliability of drug products during their expiration period. This book provides the material necessary for you to perform stability designs and analyses in pharmaceutical research and development.


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Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices

Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices

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.

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Drug Photochemistry and Stability

Drug Photochemistry and Stability

Presents the basic elements of the science, & serves as an excellent introduction to this emerging field of photochemistry. Detailed experimental conditions for photostability studies are given, along with a discussion of the recently implemented ICH Guidelines for drug photostability.

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Impurities Evaluation of Pharmaceuticals

Impurities Evaluation of Pharmaceuticals

Impurities Evaluation of Pharmaceuticals

Filling a gap in the pharmaceutical literature, this unique guide addresses the development of targeted methodologies to monitor impurities in pharmaceutical compounds and drug products. Furnishes physicochemical protocols to determine the purity of pharmaceutical compounds fully before pharmacological and toxicological studies begin! Providing a clear definition of the subject, Impurities Evaluation of Pharmaceuticals introduces various techniques for isolating and characterizing impurities presents guidelines to evaluate stability using kinetic studies shows how to develop stability-indicating methodologies details various methods that require minimal sample prepreparation gives regulatory perspectives on chiral impurities and more! Containing important literature citations and offering an invaluable list of applications, Impurities Evaluation of Pharmaceuticals is an outstanding resource for pharmacists and pharmacologists, clinical microbiologists, quality assurance and production managers in the pharmaceutical industry

, analytical chemists and biochemists, pharmaceutical regulatory personnel, and upper-level undergraduate, graduate, and continuing-education students in these disciplines.

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