Assessment of different bioequivalence metrics in rifampin bioequivalence study
DARU-Journal of Faculty of Pharmacy Tehran University of Medical Sciences. 2002; 10 (2): 54-7
em Inglês
| IMEMR
| ID: emr-59108
ABSTRACT
The use of secondary metrics has become special interest in bioequivalency studies. The applicability of partial area method, truncated AUC and Cmax/AUC has been argued by many authors. This study aims to evaluate the possible superiority of these metrics to primary metrics [i.e. AUCinf, Cmax and Tmax]. The suitability of truncated AUC for assessment of absorption extent as well as Cmax/AUC and partial AUC for the evaluation of absorption rate in bioequivalency determination was investigated following administration of same product as test and reference to 7 healthy volunteers. Among the pharmacokinetic parameters obtained, Cmax/AUCinf was a better indicator or absorption rate and the AUCinf was more sensitive than truncated AUC in evaluation of absorption extent
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Índice:
IMEMR (Mediterrâneo Oriental)
Assunto principal:
Equivalência Terapêutica
Limite:
Humanos
Idioma:
Inglês
Revista:
J. Fac. Pharm. Tehran Univ. Med. Sci.
Ano de publicação:
2002
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