1. Draft Guidance: In-vivo Bioequivalence Studies Based on Population and Individual Bioequivalence Approaches CDER;Food and Drug Administration.;Food and Drug Administration,October 1997
2. Draft Guidance: Average, Population and Individual Bapproches to Establishing Bioequivalence CDER;Food and Drug Administration.;Food and Drug Administration,August 1999
3. Draft Guidance: BA and BE Studies for Orally Adminsitered Drug Products-General Considerations CDER;Food and Drug Administration.;Food and Drug Administration,August 1999
4. Food and Drug Administration. Draft Guidance: Pharmacokinetics in Patents with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling November 11, 1999
5. Food and Drug Administration. Draft Guidance: Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action June 1999