Quality And Bioequivalence Guideline

Guideline for Bioequivalence Studies of Generic Products

Guideline for Bioequivalence Studies of Generic Products Index Section 1: Introduction Section 2: Terminology Section 3: Tests A. Oral immediate release products and enteric-coated products I. Reference and test products II. Bioequivalence studies 1. Test methods 1) Design 2) Number of subjects 3) Selection of subjects 4) Drug administration a.

  Guidelines, Bioequivalence