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Statistical Design and Analysis of Stability Studies - 9781584889052

Un libro in lingua di Shein Chow Chung edito da Taylor & Francis, 2007

  • € 85.20
  • Il prezzo è variabile in funzione del cambio della valuta d’origine

For those in pharmaceutical research and development, this volume describes the principles and methodologies in the design and analysis of stability studies. Chow (biostatistics and bioinformatics, Duke U. School of Medicine) also provides a summary of current regulatory perspectives and recently developed statistical methods in the area. Basic concepts in stability testing are explained, followed by short-term stability studies such as accelerated testing, estimating drug expiration dating periods, study designs such bracketing and matrixing, and statistical analysis with fixed batches. Other chapters cover random batches, the linear mixed effects model, discrete responses, multiple components, and frozen drug products. Testing for dissolution is discussed, including United States Pharmacopeia-National Formulary (USP-NF) testing, and scale-up and postapproval changes, mean kinetic temperature, and optimality criteria. Some chapters are revised based on chapters in Statistical Design and Analysis and Pharmaceutical Sciences. Annotation ©2007 Book News, Inc., Portland, OR (booknews.com)

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