Biopharmaceutics Classification System: A Regulatory Approach
نویسندگان
چکیده
منابع مشابه
Biopharmaceutics 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 ...
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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 demonstration of bioequivalence (BE) is an essential requirement for ensuring that patients receive a product that performs as indicated by the label. The BE standard for a particular product is set by its innovator, and this standard must subsequently be matched by generic drug products. The Biopharmaceutics Classification System (BCS) sets a scientific basis for an improved BE standard fo...
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The biopharmaceutical classification system (BCS) is now well established and utilized for the development and biowaivers of immediate oral dosage forms. The prediction of BCS class can be carried out using multilabel classification. Unlike single label classification, multilabel classification methods predict more than one class label at the same time. This paper compares two multilabel method...
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ژورنال
عنوان ژورنال: Dissolution Technologies
سال: 2011
ISSN: 1521-298X
DOI: 10.14227/dt180111p31