Generics Guidances
- CVM GFI #35 Bioequivalence Guidance
- CVM GFI #171 - Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Containing Active Pharmaceutical Ingredients Considered to Be Soluble in Aqueous Media
- CVM GFI #224 (VICH GL52) Bioequivalence: Blood Level Bioequivalence Study
- CVM GFI #224 (Supplement to VICH GL52) Supplemental Examples For Illustrating Statistical Concepts Described in the VICH In Vivo Bioequivalence Draft Guidance GL52