ASSESSMENT OF METABOLITES IN BIOEQUIVALENCE STUDIES - SHOULD BIOEQUIVALENCE CRITERIA BE APPLIED ON THE SUM OF PARENT COMPOUND AND METABOLITE

Authors
MAHMOOD I
Citation
I. Mahmood, ASSESSMENT OF METABOLITES IN BIOEQUIVALENCE STUDIES - SHOULD BIOEQUIVALENCE CRITERIA BE APPLIED ON THE SUM OF PARENT COMPOUND AND METABOLITE, International journal of clinical pharmacology and therapeutics, 36(10), 1998, pp. 540-544
Citations number
10
Categorie Soggetti
Pharmacology & Pharmacy
Journal title
International journal of clinical pharmacology and therapeutics → ACNP
ISSN journal
09461965
Volume
36
Issue
10
Year of publication
1998
Pages
540 - 544
Database
ISI
SICI code
0946-1965(1998)36:10<540:AOMIBS>2.0.ZU;2-I
Abstract
Objectives: The objective of this study was to demonstrate the impact of the sum of parent compound and metabolite in bioequivalence assessm ent. Methods: Four drugs with active metabolite were selected to asses s bioequivalence. Bioequivalence criteria of 80 - 125% were applied to the parent compound, the metabolite, and the sum of parent compound a nd metabolite. Results: The results indicated that the application of 80 - 125% bioequivalence criteria to the sum of parent compound and me tabolite might be misleading. Conclusion: The 90% confidence interval should be applied separately to the parent compound and each metabolit e.