ABSTRACT

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

chapter 5|30 pages

Regulatory Review Process

chapter 8|40 pages

Drug Delivery Factors

chapter 9|28 pages

Bioanalytical Method Validation

chapter 10|30 pages

Good Clinical Practice

chapter 12|22 pages

Computer and Software Validation

chapter 13|104 pages

Bioequivalence Reports