Statistics in the pharmaceutical industry /
| Other Authors: | , |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
Boca Raton, FL :
Chapman & Hall/CRC Taylor & Francis Group,
2006.
|
| Edition: | Third edition. |
| Series: | Biostatistics (New York, N.Y.)
|
| Subjects: |
Table of Contents:
- Introduction to the evolution of pharmaceutical products
- Statistical review and evaluation of animal carcinogenicity studies of pharmaceuticals
- The FDA and the IND/NDA statistical review process
- Clinical trial designs
- Selecting patients for a clinical trial
- Statistical aspects of cancer clinical trials
- Recent statistical issues and developments in cancer clinical trials
- Design and analysis of testosterone replacement therapy trials
- Clinical trials of analgesic drugs
- Statistical issues in HIV/AIDS research
- The wonders of placebo
- Active-controlled noninferiority/equivalence trials : methods and practice
- Interim analysis and bias in clinical trials : the adaptive design perspective
- Interim analysis and adaptive design in clinical trials
- A regulatory perspective on data monitoring and interim analysis
- Complex adaptive system, human health and drug response : statistical challenges in pharmacogenomics
- Phase IV postmarketing studies
- The role of contract research organizations in clinical research in the pharmaceutical industry
- Global harmonization of drug development - a clinical statistics perspective
- Bridging strategies in global drug development
- Design and analysis strategies for clinical pharmacokinetic trials
- Stability studies of pharmaceuticals
- When and how to do multiple comparisons
- Reference intervals (ranges) : distribution-free methods vs. normal theory