منابع مشابه
Strategies for the Bioequivalence Assessment of Topical Dermatological Dosage Forms
The pharmacokinetic approach used for the BE assessment of systemically absorbed drugs is not considered appropriate to study the bioavailability (BA) and/or BE of topically applied drugs other than dosage forms such as transdermal patches and other products intended for local application which contain drugs intended for the systemic circulation. Apart from the analytical difficulty of measurin...
متن کاملDiffusion of preservatives from topical dosage forms: a comparative study.
A study of the diffusion of parabens from topical formulations is presented here. In particular, four different topical formulations, namely, a water-in-oil emulsion, an oil-in-water emulsion, and two hydrophilic gels (Pemulen gel and Carbopol gel) were produced, containing a mixture of three common parabens, namely, methylparaben (MP), ethylparaben (EP), and propylparaben (PP). An analytical m...
متن کاملChallenges obtaining a biowaiver for topical veterinary dosage forms.
Obtaining a biowaiver for topical drugs used in veterinary species faces many of the same challenges associated with human topicals. However, the skin of domestic animals varies anatomically and biochemically and experimental approaches to assess bioequivalence (BE) in veterinary species have challenges that are not often encountered with human skin. This is especially the situation with locall...
متن کاملAceclofenac topical dosage forms: in vitro and in vivo characterization.
Aceclofenac is a new generation non-steroidal anti-inflammatory drug showing effective anti-inflammatory and analgesic properties. It is available in the form of tablets of 100 mg. Importance of aceclofenac as a NSAID has inspired development of topical dosage forms. This mode of administration may help avoid typical side effects associated with oral administration of NSAIDs, which have led to ...
متن کاملA Pharmacokinetic Bioequivalence Study Comparing Pirfenidone Tablet and Capsule Dosage Forms in Healthy Adult Volunteers
INTRODUCTION Pirfenidone film-coated tablets were developed to offer an alternative to the marketed capsule formulation. This study assessed the bioequivalence of the tablet and capsule formulations under fed and fasted states. METHODS A Phase I, open-label, randomized, four-treatment-period, four-sequence, crossover pharmacokinetics study (NCT02525484) was conducted. Each subject received an...
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ژورنال
عنوان ژورنال: Journal of Pharmacovigilance
سال: 2014
ISSN: 2329-6887
DOI: 10.4172/2329-6887.1000e118