Bioequivalence and Bioavailability Forum

jag009 ★★★ NJ, 2018-09-07 22:31 (2050 d 10:31 ago) Posting: # 19251 Views: 2,141	FDA Supac guidance for ER [Regulatives / Guidelines] Post reply
	Hi, Question. To support SUPAC (post approval manufacturing site change) filing for ER products, do we need to perform multimedia dissolution testings? Thanks John

Helmut
★★★

Vienna, Austria,
2018-09-09 16:04
(2048 d 16:58 ago)

@ jag009
Posting: # 19253
Views: 1,773

FDA Supac guidance for ER

Post reply

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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jag009 ★★★ NJ, 2018-09-10 20:38 (2047 d 12:25 ago) @ Helmut Posting: # 19256 Views: 1,721	FDA Supac guidance for ER Post reply
	Thank Helmut!

FDA Supac guidance for ER [Regulatives / Guidelines]

FDA Supac guidance for ER

FDA Supac guidance for ER