PMID: 11934233Apr 6, 2002Paper

Comparison of dermatopharmacokinetic vs. clinicial efficacy methods for bioequivalence assessment of miconazole nitrate vaginal cream, 2% in humans

Pharmaceutical Research
Lynn K PershingJoel L Nelson

Abstract

To compare the dermatopharmacokinetic vs. clinical trial methods for bioequivalence assessment of two miconazole nitrate vaginal cream, 2% products. The dermatopharmacokinetic method determined the bioequivalence of two products simultaneously in 24 healthy subjects, as a function of Cmax and AUC(0-1) parameters using miconazole nitrate content in harvested volar forearm stratum corneum. The clinical trial method determined bioequivalence as a function of clinical, mycological culture and therapeutic cure(s) after 7 days of product use and 30 days after therapy cessation in 106 female subjects with positive signs and symptoms of vaginitis, KOH vaginal smears and Candida cultures, randomly assigned to test or reference product. The dermatopharmacokinetic method demonstrated that the two products were not bioequivalent, while the clinical trial method concluded bioequivalence. The dermatopharmacokinetic method allowed simultaneous evaluation of both products in the same subject, within the same study period, and was more sensitive and discriminating in the assessment of bioequivalence between the two miconazole nitrate vaginal cream, 2% products than the clinical trial method.

Citations

May 2, 2008·Pharmaceutical Research·Berthe N'Dri-StempferAnnette L Bunge
Nov 11, 2017·Pain Management·Nebojsa Nick KnezevicKenneth D Candido
Aug 25, 2020·Acta Crystallographica Section B, Structural Science, Crystal Engineering and Materials·Nerith Rocio ElejaldeJaime Portilla
Jul 13, 2006·Journal of Applied Toxicology : JAT·Lynn K PershingWarren W Jederberg
Oct 23, 2008·Pharmaceutical Research·Berthe N'Dri-StempferAnnette L Bunge
Apr 23, 2009·Expert Opinion on Drug Delivery·L M Russell, R H Guy
May 10, 2008·Journal of Pharmacokinetics and Pharmacodynamics·William NavidiAnnette Bunge
Oct 15, 2013·Biopharmaceutics & Drug Disposition·Anroop B NairIbrahim A Alhaider
May 8, 2003·Journal of the American Academy of Dermatology·Lynn K PershingVinod P Shah

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