Statistical Considerations: Alternate Designs and Approaches for Bioequivalence Assessments

Click to increase image sizeClick to decrease image size

Notes

5 Statistical Considerations for Clinical Trials in Developing Antimicrobial Drugs, Anti-infective Drug Products Advisory Committee; July 29, 1998. Daphne Lin, Ph.D., CDER/OFB/DBIV.

6 Guidance for Industry, Bioavailability and Bioequivalence Studies for Orally Administered Drug Products, Genereal Considerations, CDER; 2003.

7 Guidance for Industry, Statistical Approaches to Establishing Bioequivalence, CDER; 2001.

8 Guidance for Industry, Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing, Center for Drug Evaluation and Research (CDER); June 2005.