• Biopharmaceutical Classification System Bcs Of Drugs
• Bcs Classification System Slideshare

There are some criticisms of the use of BCS that fail in taking into account the dynamic system that occurs in vivo. An example of this is non-steroidal anti-inflammatory drugs that are classified as II and show extensive absorption. The biopharmaceutics drug disposition classification system (BDDCS). Current guidelines (CPMP Note for Guidance in Europe and FDA Guidance for Industry in the USA) consider a waiver of bioavailability/bioequivalence studies.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled “Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System.” This guidance finalizes recommendations for sponsors of investigational new drug applications (INDs), and applicants who submit new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements to these applications for immediate-release (IR) solid oral dosage forms, and who wish to request a waiver of an in vivo bioavailability (BA) and/or bioequivalence (BE) study requirement.

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Biopharmaceutical Classification System Bcs Of Drugs

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

Bcs Classification System Slideshare

All written comments should be identified with this document's docket number: FDA-2015-D-1245.

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