Biopharmaceutics classification system: importance and inclusion in biowaiver guidance
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...
متن کاملBiopharmaceutics Classification System: A Regulatory Approach
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 ...
متن کاملRisk assessment for extending the Biopharmaceutics Classification System-based biowaiver of immediate release dosage forms of fluconazole in adults to the paediatric population.
OBJECTIVES The paediatric population undergoes developmental changes in gastric pH, gastric emptying, intestinal transit time, membrane permeability, protein binding, body water, distribution and metabolism. It is widely recognised that changes in these parameters may result in an alteration of the plasma profile and thus in key bioequivalence parameters such as Cmax (maximum plasma concentrati...
متن کاملCOMMENTARY Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms Based on Biopharmaceutics Classification System (BCS) Literature Data: Chloroquine Phosphate, Chloroquine Sulfate, and Chloroquine Hydrochloride
Literature data on the properties of chloroquine phosphate, chloroquine sulfate, and chloroquine hydrochloride related to the Biopharmaceutics Classification System (BCS) are reviewed. The available information indicates that these chloroquine salts can be classified as highly soluble and highly permeable, i.e., BCS class I. The qualitative composition of immediate release (IR) tablets containi...
متن کاملCOMMENTARY Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms Based on Biopharmaceutics Classification System (BCS) Literature Data: Verapamil Hydrochloride, Propranolol Hydrochloride, and Atenolol
Literature data related to the Biopharmaceutics Classification System (BCS) are presented on verapamil hydrochloride, propranolol hydrochloride, and atenolol in the form of BCS-monographs. Data on the qualitative composition of immediate release (IR) tablets containing these active substances with a Marketing Authorization (MA) in the Netherlands (NL) are also provided; in view of these MA’s th...
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ژورنال
عنوان ژورنال: Brazilian Journal of Pharmaceutical Sciences
سال: 2015
ISSN: 1984-8250
DOI: 10.1590/s1984-82502015000100015