The revised ICH Guidelines will include tools for demonstrating equivalence (e.g., bioequivalence) for non-complex dosage forms and more complex dosage forms and products.
The following ICH Efficacy guidelines might be revised to include recommendations on:
- The conduct of comparative clinical endpoint bioequivalence studies: E3 (Clinical Study Reports), E6 (GCP), E8 (General Considerations for Clinical Trials), E9 (Statistical Principles for Clinical Trials), E10 (Choice of Control Group in Clinical Trials), E17 (Multi-Regional Clinical Trials)
- Pharmacovigilance for generic drugs: E2
- Identification of products with a narrow therapeutic index: E4 (Dose-Response Studies)
- Statistical considerations for bioequivalence: E9 (Statistical Principles for Clinical Trials)
More information can be found here.