Statistical Design and Analysis of Stability Studies

Sampul Depan
CRC Press, 30 Mei 2007 - 349 halaman
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 sta
 

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Chapter 1 Introduction
1
Chapter 2 Accelerated Testing
25
Chapter 3 Expiration Dating Period
53
Chapter 4 Stability Designs
73
Chapter 5 Stability Analysis with Fixed Batches
99
Chapter 6 Stability Analysis with Random Batches
125
Chapter 7 Stability Analysis with a Mixed Effects Model
165
Chapter 8 Stability Analysis with Discrete Responses
175
Chapter 10 Stability Analysis with Frozen Drug Products
193
Chapter 11 Stability Testing for Dissolution
203
Chapter 12 Current Issues and Recent Developments
233
Guidance for Industry
273
SAS Marco Files for STAB System for Stability Analysis
293
References
307
Index
323
Back cover
331

Chapter 9 Stability Analysis with Mulitiple Components
187

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