Handbook of bioequivalence testing

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