Generic Drug Product Development
Bioequivalence Issues
edited by Leon Shargel

Generic Drug Product Development: Bioequivalence Issues describes specific bioequivalence issues which need to be considered for the design and conduct of bioequivalence studies.

By exploring scientific, legal, and international regulatory challenges, the book discusses the use of alternative approaches to the measurement of plasma drug concentrations for the demonstration of bioequivalence, and covers bioequivalence procedures for drug products that are not easily assessed - based upon the physical and chemical properties of the active drug and the nature of the drug product.

Features:

• provides information on the FDA's approach for the choice of a reference product for use in a bioequivalence study
• details the application of bioequivalence for the assessment of the safety and efficacy of generic drugs
• gives an account of pharmaceutical alternatives such as different salts and/or different dosage which contain the same API and the issues of therapeutic equivalence and interchangeability
• provides readers with a comprehensive account of population pharmacokinetic approaches to assess bioequivalence, including compartmental versus non-compartmental pharmacokinetic approaches
• a comprehensive account of the scientific, and regulatory considerations for determination of bioequivalence
• alternate approaches to bioequivalence including statistical designs, pharmacodymic and clinical endpoints

Contents

1. Introduction - Bioequivalence Issues
2. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
3. Pharmaceutical Alternatives: Considerations for Generic Substitution
4. Pharmacodynamic Measurements for Determination of Bioequivalence
5. Bioequivalence Using Clinical Endpoint Studies
6. Evaluation of Bioequivalence of Highly-Variable Drug Products
7. Statistical Considerations: Alternate Designs And Approaches for Bioequivalence Assessments
8. Population Pharmacokinetic Approaches for Assessing Bioequivalence
9. Role of Metabolites in Bioequivalence Assessment
10. Implications of Chirality for the Assessment of Bioequivalence
11. Effect of Food on Bioavailability and the Assessment of Bioequivalence
12. Bioequivalence Assessment of Endogenous Drug Substances: Pharmacokinetics and Statistical Evaluation

Glossary
Index

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