Handbook of bioequivalence testing
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| Main Author: | |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
New York, NY
Informa Healthcare
2007
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| Series: | Drugs and the pharmaceutical sciences
v.171 |
| Subjects: | |
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Table of Contents:
- Bioequivalence testing rationale and principles
- Regulatory aspect of bioequivalence testing
- Pharmacokinetic/pharmacodynamic modeling
- Waiver of bioavailability/bioequivalence studies
- Regulatory review process
- Statistical evaluation of bioequivalence data
- Physicochemical properties affecting bioequivalence
- Drug delivery factors
- Bioanalytical method validation
- Good clinical practice
- Good laboratory practice for nonclinical laboratory studies
- Computer and software validations
- Bioequivalence reports.