The Role of BCS (Biopharmaceutics Classification System) and BDDCS (Biopharmaceutics Drug Disposition Classification System) in Drug Development
نویسندگان
چکیده
منابع مشابه
BIOPHARMACEUTICS DRUG DISPOSITION CLASSIFICATION SYSTEM: AN EXTENSION OF BIOPHARMACEUTICS CLASSIFICATION SYSTEM Kataria
The Biopharmaceutics Classification System (BCS) was developed for prediction of in vivo pharmacokinetic performance of drug products from measurements of permeability and solubility. If the permeability criteria changed with metabolism criteria than it may be useful in predicting overall drug disposition, including routes of drug elimination and the effects of efflux and absorptive transporter...
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The main objective of this work was to investigate in-silico predictions of physicochemical properties, in order to guide oral drug development by provisional biopharmaceutics classification system (BCS). Four in-silico methods were used to estimate LogP: group contribution (CLogP) using two different software programs, atom contribution (ALogP), and element contribution (KLogP). The correlatio...
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The Biopharmaceutics Classification System (BCS) is the result of continuous efforts in mathematical analysis for the elucidation of the kinetics and dynamics of the drug process in the gastrointestinal tract (GIT) for NDA (New Drug Application) and ANDA (Abbreviated New Drug Application) filings and biowaivers. This step reduces timelines in the new drug development process, both directly and ...
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The biopharmaceutics classification system (BCS) and biopharmaceutics drug distribution classification system (BDDCS) are complementary classification systems that can improve, simplify, and accelerate drug discovery, development, and regulatory processes. Drug permeability has been widely accepted as a screening tool for determining intestinal absorption via the BCS during the drug development...
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The objective was to assess the impact of larger than conventional amounts of 14 commonly used excipients on Biopharmaceutics Classification System (BCS) class 3 drug absorption in humans. Cimetidine and acyclovir were used as model class 3 drugs across three separate four-way crossover bioequivalence (BE) studies (n = 24 each) in healthy human volunteers, denoted as study 1A, 1B, and 2. In stu...
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ژورنال
عنوان ژورنال: Journal of Pharmaceutical Sciences
سال: 2013
ISSN: 0022-3549
DOI: 10.1002/jps.23359