The phenytoin trial is a case study of 'individual' bioequivalence

Drug Information Journal

Volumn 32, Issue 4, 1998, Pages 1063-1072

  Shumaker, R C ^a   Metzler, C M ^b  

^a ALPHARMA   (United States)

^b Nutwood Associates   (United States)

Author keywords

Individual bioequivalence; Phenytoin

Indexed keywords

ANTICONVULSIVE AGENT; PHENYTOIN;

ADULT; ANTICONVULSANT THERAPY; BIOEQUIVALENCE; CLINICAL TRIAL; CROSSOVER PROCEDURE; DRUG BIOAVAILABILITY; DRUG FORMULATION; FOOD AND DRUG ADMINISTRATION; HUMAN; MALE; NORMAL HUMAN; ORAL DRUG ADMINISTRATION; PRIORITY JOURNAL; REFERENCE VALUE; REVIEW; SEIZURE; STATISTICAL PARAMETERS;

EID: 0031795947     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286159803200426     Document Type: Review

References (5)

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3. Schall R, Williams RL. Towards a practical strategy for assessing individual bioequivalence. J Pharmacokin Biopharm. 1996;24(1):133-149.
4. Vuorinen J, Turunen J. A simple three-step procedure for parametric and nonparametric assessment of bioequivalence. Drug Inf J. 1997;31(1):167-180.
5. Chen L. Individual bioequivalence - A regulatory update. J Biopharm Statist. 1997;7(1):5-11.