I Mahmood1. 1. Office of Clinical Pharmacology and Biopharmaceutics, Division of Pharmaceutical Evaluation I., Food and Drug Administration, Rockville, MD 20852, USA.
Abstract
OBJECTIVES: The objective of this study was to demonstrate the impact of the sum of parent compound and metabolite in bioequivalence assessment. METHODS: Four drugs with active metabolite were selected to assess bioequivalence. Bioequivalence criteria of 80 - 125% were applied to the parent compound, the metabolite, and the sum of parent compound and metabolite. RESULTS: The results indicated that the application of 80 - 125% bioequivalence criteria to the sum of parent compound and metabolite might be misleading. CONCLUSION: The 90% confidence interval should be applied separately to the parent compound and each metabolite.
RCT Entities:
OBJECTIVES: The objective of this study was to demonstrate the impact of the sum of parent compound and metabolite in bioequivalence assessment. METHODS: Four drugs with active metabolite were selected to assess bioequivalence. Bioequivalence criteria of 80 - 125% were applied to the parent compound, the metabolite, and the sum of parent compound and metabolite. RESULTS: The results indicated that the application of 80 - 125% bioequivalence criteria to the sum of parent compound and metabolite might be misleading. CONCLUSION: The 90% confidence interval should be applied separately to the parent compound and each metabolite.
Authors: Joel M Reid; Sumithra J Mandrekar; Elsa C Carlson; W Scott Harmsen; Erin M Green; Renee M McGovern; Eva Szabo; Matthew M Ames; Daniel Boring; Paul J Limburg Journal: Cancer Epidemiol Biomarkers Prev Date: 2008-03 Impact factor: 4.254