FDA Supac guidance for ER [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2018-09-09 14:04 (747 d 14:41 ago) – Posting: # 19253
Views: 1,273

Hi John,

» To support SUPAC (post approval manufacturing site change) filing for ER products, do we need to perform multimedia dissolution testings?

Generally not. That’s a Level 3 Change.
See the guidance V. C. 2. b. Dissolution documentation:

In addition to application/compendial release requirements, a multipoint dissolution profile should be obtained using application/compendial test conditions for the changed drug product and the biobatch or marketed batch (unchanged drug product). Adequate sampling should be performed, for example at 1, 2, and 4 hours and every two hours thereafter until either 80% of the drug from the drug product is released or an asymptote is reached.

But don’t forget V. C. 2. c. Bioequivalence documentation:

A single-dose bioequivalence study. The bioequivalence study may be waived in the presence of an established in vitro/in vivo correlation.

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Helmut Schütz

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