jag009
★★★

NJ,
2018-09-07 22:31
(2028 d 12:04 ago)

Posting: # 19251
Views: 2,089
 

 FDA Supac guidance for ER [Regulatives / Guidelines]

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
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Vienna, Austria,
2018-09-09 16:04
(2026 d 18:31 ago)

@ jag009
Posting: # 19253
Views: 1,735
 

 FDA Supac guidance for ER

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
(2025 d 13:58 ago)

@ Helmut
Posting: # 19256
Views: 1,679
 

 FDA Supac guidance for ER

Thank Helmut!
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