The transitivity of bioequivalence testing: Potential for drift

International Journal of Clinical Pharmacology and Therapeutics

Volumn 34, Issue 9, 1996, Pages 369-374

  Anderson, S ^a,b   Hauck, W W ^b  

^a BRISTOL MYERS SQUIBB   (United States)

^b THOMAS JEFFERSON UNIVERSITY   (United States)

Author keywords

Bioequivalence; Drug development; Generic drugs

Indexed keywords

GENERIC DRUG;

ARTICLE; BIOEQUIVALENCE; DRUG BIOAVAILABILITY; DRUG FORMULATION; DRUG MANUFACTURE;

CHEMISTRY, PHARMACEUTICAL; DRUGS, GENERIC; HUMANS; RESEARCH DESIGN; STATISTICS; THERAPEUTIC EQUIVALENCY;

EID: 0029831888     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (3)

1. Anderson S, Hauck WW 1990 Consideration of individual bioequivalence. J Pharmacokinet Biopharm 18: 259-273
2. Diletti E, Hauschke D, Steinijans VW 1991 Sample size determination for bioequivalence assessment by means of confidence intervals. Int J Clin Pharmacol Ther Toxicol 29: 1-8
3. 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