ABSTRACT

As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence. In addition, advances in the analytical technology used to detect drug and metabolite levels have m

chapter 3|40 pages

Drug Delivery Factors

chapter 6|44 pages

Bioequivalence Waivers

chapter 8|32 pages

Regulatory Inspection Process

chapter 9|8 pages

Fed Bioequivalence Studies

chapter 10|8 pages

Topical Drugs

chapter 11|22 pages

Bioequivalence of Nasal Products

chapter 13|62 pages

Bioequivalence of Biosimilar Products

chapter 14|34 pages

Bioequivalence Testing: The U.S. Perspective

chapter 15|36 pages

Bioequivalence Testing: European Perspective

chapter 16|56 pages

Bioequivalence Testing: The ROW Perspective

chapter 17|72 pages

Bioequivalence Testing Protocols

chapter 18|38 pages

Bioequivalence Documentation

chapter 19|36 pages

Good Laboratory Practices

chapter 20|42 pages

Bioanalytical Method Validation

chapter 21|32 pages

Good Clinical Practice

chapter 22|20 pages

Computer and Software Validation

chapter 24|18 pages

Epilog: Future of Bioequivalence Testing