Handbook of Bioequivalence TestingCRC Press, 2007. gada 22. aug. - 550 lappuses As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct efficient and successful bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence, and advances in the analytical technology used to detect drug and metabolite levels have made |
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Saturs
Chapter 1 Bioequivalence Testing Rationale and Principles | 1 |
Chapter 2 Regulatory Aspects of Bioequivalence Testing | 45 |
Chapter 3 Pharmacokinetic and Pharmacodynamic Modeling | 61 |
Chapter 4 Waiver of BioavailabilityBioequivalence Studies | 69 |
Chapter 5 Regulatory Review Process | 89 |
Chapter 6 Statistical Evaluation of Bioequivalence Data | 119 |
Chapter 7 Physicochemical Properties Affecting Bioequivalence | 163 |
Chapter 8 Drug Delivery Factors | 197 |
Chapter 11 Good Laboratory Practices for Nonclinical Laboratory Studies | 295 |
Chapter 12 Computer and Software Validation | 317 |
Chapter 13 Bioequivalence Reports | 339 |
Glossary of Terms | 443 |
Bioequivalence Testing Literature | 461 |
Dissolution Testing Methods of Approved Drugs | 535 |
553 | |
Back cover | 575 |
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