Statistical Design and Analysis of Stability StudiesCRC 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 |
Sommario
| 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 |
| 307 | |
| 323 | |
Back cover | 331 |
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Statistical Design and Analysis of Stability Studies Shein-Chung Chow Anteprima non disponibile - 2020 |
Statistical Design and Analysis of Stability Studies Shein-Chung Chow Anteprima non disponibile - 2007 |
Parole e frasi comuni
1987 FDA stability active ingredient application Arrhenius equation assay asymptotic batch-to-batch variation Biopharmaceutical Chapter Chow and Shao common slope components confidence interval considered covariance covariance matrix defined degradation line degradation rate degrees of freedom design factors dissolution profiles dissolution testing dosage forms drug characteristic drug product drug shelf-life drug substance effects model estimated shelf-life expiration dating period factorial design FDA stability guideline fractional factorial design given guideline for stability intercepts label claim least squares estimates level of significance levothyroxine sodium linear regression long-term stability studies lower confidence bound manufacturing matrixing design mean degradation mean squared error null hypothesis p-value package type pharmaceutical production batches proposed quantile random effects model requirements retest period Ruberg sampling time points Section shelf-life estimation stability analysis stability data stability design stability testing strength sum of squares TABLE three batches Uniform uniform matrix USP-NF variability variance
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...
Riferimenti a questo libro
Statistical Design and Analysis in Pharmaceutical Science: Validation ... Shein-Chung Chow,Jen-pei Liu Anteprima non disponibile - 1995 |