Bioequivalence assessment and the conduct of bioequivalence trials: A European point of view

European Journal of Drug Metabolism and Pharmacokinetics

Volumn 21, Issue 2, 1996, Pages 149-152

  Herchuelz, A ^a,b  

^a FREE UNIVERSITY OF BRUSSELS   (Belgium)

^b UNIVERSITÉ LIBRE DE BRUXELLES   (Belgium)

Author keywords

Bioequivalence assessment; Bioequivalence trials; European view; Generic drugs

Indexed keywords

GENERIC DRUG;

BIOEQUIVALENCE; CONFERENCE PAPER; DRUG BIOAVAILABILITY; DRUG LEGISLATION; EUROPE; HUMAN;

EID: 0030017104     PISSN: 03787966     EISSN: None     Source Type: Journal    
DOI: 10.1007/BF03190263     Document Type: Conference Paper

References (4)

1. Investigation of bioavailability and bioequivalence (1991) : The rules governing medicinal products in the European Community. Vol III, addendum 2, 149-169.
2. Schuirmann D.J. (1987) : A comparison of the two one-sided tests procedure and power approach for assessing the equivalence of average bioavailability J. Pharmacokinet. Biopharmacol., 15, 657-680.
3. Hauschke D, Sleinijans V.W., Diletti E. (1990) . A distribution-free procedure for the statistical analysis of bioequivalence studies. Int. J. Clin. Pharmacol. Ther. Toxicol., 28, 72-78.
4. Marzo A., Balant L.P. (1995) : Bioequivalence. An updated reappraisal addressed to application of interchangeable multi-source pharmaceutical products. Arzneimittelforschung, 45, 109-115.