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

Volumn 36, Issue 10, 1998, Pages 540-544

  Mahmood, I ^a,b  

^a Off Clin Pharmacol Biopharmaceut   (United States)

^b Woodmont Office Center II   (United States)

Author keywords

Bioequivalence; Confidence interval; Metabolite; Parent compound; Sum of parent and metabolite

Indexed keywords

DRUG METABOLITE;

ARTICLE; BIOEQUIVALENCE; DRUG BLOOD LEVEL;

AREA UNDER CURVE; BIOTRANSFORMATION; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DOPAMINE AGONISTS; DOUBLE-BLIND METHOD; ERGOLINES; HUMANS; THERAPEUTIC EQUIVALENCY;

EID: 0031720437     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (10)

1. Blume HH, Midha KK 1993 Bio-International '92, Conference on bioavailability, bioequivalence, and pharmacokinetic studies. Pharm Res 10: 1806-1811
2. Chen ML, Jackson A 1991 The role of metabolites in bioequivalency assessment. I. Linear pharmacokinetics without first-pass effect. Pharm Res 8: 25-32
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7. Ormsby E 1994 Statistical methods in bioequivalence. In: Jackson AE (ed) Generics and Bioequivalence. CRC Press, Ann Arbor
8. Schuirmann DJ 1987 A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm 15: 657-680
9. Shargel L, Yu A 1993 Applied Biopharmaceutics and Pharmacokinetics (3rd edition). Appleton and Lange, Norwalk, Connecticut
10. Tucker GT, Rostami A, Jackson PR 1992 Metabolite measurement in bioequivalence studies. I. Theoretical considerations, presented at Bio-International '92, Conference on Bioavailability, Bioequivalence, and Pharmacokinetic Studies. Bad-Homburg/Frankfurt, May 20-22