Clinical relevance of bioequivalence acceptance criteria: The example of terbinafine

Arzneimittel-Forschung/Drug Research

Volumn 53, Issue 4, 2003, Pages 289-293

  Koytchev, Rossen ^a,e   Erenmemisoglu, Aydin ^b   Van Der Meer, Mike John ^c   Alpan, Serdar ^d  

^a Coop Clin Drug Res/Development ^*  (Germany)

^b ERCIYES UNIVERSITY MEDICAL FACULTY   (Turkey)

^c Trident Bioanalytics Ltd   (Ireland)

^d YEDITEPE UNIVERSITY   (Turkey)

^e CCDRD AG   (Germany)

Author keywords

Antimycotics; Bioequivalence, acceptance criteria; CAS 78628 80 5; Terbinafine, acceptance criteria for bioequivalence, clinical studies

Indexed keywords

ANTIFUNGAL AGENT; CAS 78628 80 5; TERBINAFINE;

ADULT; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; CALCULATION; DRUG BIOAVAILABILITY; DRUG DETERMINATION; DRUG EFFICACY; DRUG MECHANISM; DRUG SAFETY; HUMAN; LIQUID CHROMATOGRAPHY; MALE; MASS SPECTROMETRY; NORMAL HUMAN; OPEN STUDY; PARAMETRIC TEST; PLASMA; QUANTITATIVE ANALYSIS;

EID: 0038069450     PISSN: 00044172     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-0031-1297110     Document Type: Article

References (8)

1. Birnbaum, J. E. Pharmacology of the allylamines. J. Am. Acad. Dermatol. 23, 782 (1990)
2. Product Information: Lamisil®, terbinafine hydrochloride. Novartis Pharma, Basel (2001)
3. Jensen, J. C. Clinical pharmacokinetics of terbinafine (Lamisil). Clin. Exp. Dermatol. 14, 110 (1989)
4. Kovarik, J. M., Kirkessell, S., Humbert, H. et al., Doseproportional pharmacokinetics of terbinafine and its N-demethylated metabolite in healthy volunteers. Br. J. Dermatol. 126 (Suppl. 39), 8 (1992)
5. Heinzel, G., Woloszczak, R., Thomann, TopFit 2.0, pharmacokinetic and pharmacodynamic data analysis system for the PC. Gustav Fischer, Stuttgart - Jena etc. (1993)
6. Hauschke, D., Steinijans, V. W., Diletti, E., A distribution free procedure for the statistical analysis of bioequivalence studies. Int. J. Clin. Pharmacol. Ther. Toxicol. 28, 72 (1990)
7. CPMP Note for guidance: Investigation of bioavailability and bioequivalence (CPMP/EWP/QWP/1401/98)
8. Petranyi, G., Moingassner, J. G., Mleth, H., Antifungal activity of the allylamine derivative terbinafine in vitro. Antimicrob. Agents Chemother. 31, 1365 (1987)