Statistical Design and Analysis of Stability Studies

Copertina anteriore
CRC Press, 30 mag 2007 - 349 pagine
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
 

Cosa dicono le persone - Scrivi una recensione

Nessuna recensione trovata nei soliti posti.

Sommario

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

Altre edizioni - Visualizza tutto

Parole e frasi comuni

Brani popolari

Pagina 2 - Active ingredient means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals.
Pagina xvii - This book series will provide comprehensive and unified presentations of statistical designs and analyses of important applications in biostatistics, such as those in biopharmaceuticals. A well-balanced summary will be given of current and recently developed statistical methods and interpretations for both statisticians and researchers/scientists with minimal statistical knowledge who are engaged in the field of applied biostatistics.
Pagina iii - Dalene K. Stangl and Donald A. Berry 5. Generalized Linear Models: A Bayesian Perspective, Dipak K. Dey, Sujit K. Ghosh, and Bani K. Mallick 6. Difference Equations with Public Health Applications, Lemuel A. Moye and Asha Seth Kapadia 7. Medical Biostatistics, Abhaya Indrayan and Sanjeev B. Sarmukaddam 8. Statistical Methods for Clinical Trials, Mark X. Norleans 9. Causal Analysis in Biomedicine and Epidemiology: Based on Minimal Sufficient Causation, Mikel Aickin 10. Statistics in Drug Research:...
Pagina 320 - ... changes: chemistry, manufacturing and controls, in vitro dissolution testing and in vivo bioequivalence documentation...
Pagina 2 - ... direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. The term includes those com-ponents that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect. (8) Inactive ingredient means any component other than an active ingredient.
Pagina xvii - Biostatistics series are to provide useful reference books for researchers and scientists in academia, industry, and government, and to offer textbooks for undergraduate and/or graduate courses in the area of biostatistics. This book series will provide comprehensive and unified presentations of statistical designs and analyses of important applications in biostatistics, such as those in biopharmaceuticals. A wellbalanced summary...

Informazioni bibliografiche