Avraham Yacobi

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This is a summary report of the conference on Analytical Methods Validation: Bioavailability, Bioequivalence and Pharmacokinetic Studies. The conference was held from December 3 to 5, 1990 in the Washington, DC area and was sponsored by the American Association of Pharmaceutical Scientists, US Food and Drug Administration, Federation International(More)
This report is a synthesis of (1) the earlier conference on Analytical Methods Validation−Bioavailability, Bioequivalence and Pharmacokinetic Studies (Conference held in Arlington, VA, December 3–5, 1990 and the report published in Pharmaceutical Research, 9: 588-592, 1992) and (2) the workshop on “Bioanalytical Methods Validation—A Revisit with a Decade of(More)
Plasma or serum protein binding determinations of extensively bound drugs are subject to serious error if the analytical methods employed do not discriminate between such drugs and their degradation products, metabolites, and impurities. Experimental evidence is presented to demonstrate the magnitude of this problem with respect to warfarin.
The protein binding of racemic 14 C-warfarin and 3 H-S(-)-warfarin was determined in individual undiluted serum samples from 31 human subjects and 11 rats. The free fraction value of the R(+) enantiomer was determined indirectly from the free fraction values of the S(−) enantiomer and racemic warfarin, a method which was verified by direct determination of(More)
The pharmacokinetic values of d,l-leucovorin and l-leucovorin were compared in eight healthy volunteers following oral administration of 25 mg d,l-leucovorin and 12.5 mg l-leucovorin. Serum levels of l-5-for-myltetrahydrofolate, l-5-methyltetrahydrofolate, and total reduced folates were measured by an established microbiological method. Pharmacokinetic data(More)
Twenty healthy adult volunteers received single 400 mg oral doses of cefixime in an open, randomized, crossover study, administered twice in the fasted state and twice with a standard breakfast. The study design allowed both an evaluation of a potential food effect and also an analysis of both intrasubject and intersubject variability in the fasted and fed(More)
This paper summarises the proceedings of a recent workshop which brought together pharmaceutical scientists and dermatologists from academia, industry and regulatory agencies to discuss current regulatory issues and industry practices for establishing therapeutic bioequivalence (BE) of dermatologic topical products. The methods currently available for(More)