jag009
★★★

NJ,
2018-09-07 22:31
(2029 d 04:32 ago)

Posting: # 19251
Views: 2,093
 

 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
★★★
avatar
Homepage
Vienna, Austria,
2018-09-09 16:04
(2027 d 10:59 ago)

@ jag009
Posting: # 19253
Views: 1,739
 

 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.


Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
jag009
★★★

NJ,
2018-09-10 20:38
(2026 d 06:25 ago)

@ Helmut
Posting: # 19256
Views: 1,683
 

 FDA Supac guidance for ER

Thank Helmut!
UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
66 visitors (0 registered, 66 guests [including 11 identified bots]).
Forum time: 02:03 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5