Statistical Design And Analysis Of Stability Studies (Chapman & Hall/Crc Biostatistics Series)

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. Features, Introduces short-term stability studies, such as accelerated testing for obtaining a tentative drug shelf life, Describes various stability designs, such as bracketing and matrixing designs for new drug application stability studies, Focuses on the estimation of drug shelf life based on both fixed batch effects and random batch effects approaches, Summarizes current regulatory practices, including the US Pharmacopeia-National Formulary in vitro dissolution testing and dissolution profile testing, Discusses the recent developments of scale up and postapproval, mean kinetic temperature, and optimal criteria for choosing appropriate stability designs Book jacket.

• | Author: Shein-Chung Chow
• | Publisher: Routledge
• | Publication Date: Jun 30, 2020
• | Number of Pages: 348 pages
• | Language: English
• | Binding: Paperback
• | ISBN-10: 0367577682
• | ISBN-13: 9780367577681