Bioequivalence and Bioavailability Forum • Health Canada: Release of Draft Guidance BCS biowaiver

luvblooms
★★

India,
2012-08-31 11:14
(5046 d 10:17 ago)

Posting: # 9132
Views: 2,194

Health Canada: Release of Draft Guidance BCS biowaiver [Regulatives / Guidelines]

Dear All

Good morning

On August 21, 2012 Health Canada has released of the draft guidance document Biopharmaceutics Classification System Based Biowaiverfor stakeholder consultation (Link).

This is applied to Biopharmaceutics Classification System (BCS) Class I and III drugs and the scope of this document is limited to immediate-release, solid oral pharmaceutical drug products regulated under the Food and Drugs Act that are intended to deliver medication to the systemic circulation.

Edit: Duplicate post deleted [Ohlbe]

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