Bioequivalence and Bioavailability Forum 02:57 CET

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

jag009
Hero

NJ,
2018-09-07 20:31

Posting: # 19251
Views: 488
 

 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
Hero
avatar
Homepage
Vienna, Austria,
2018-09-09 14:04

@ jag009
Posting: # 19253
Views: 380
 

 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.


Cheers,
Helmut Schütz
[image]

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

NJ,
2018-09-10 18:38

@ Helmut
Posting: # 19256
Views: 319
 

 FDA Supac guidance for ER

Thank Helmut!
Activity
 Thread view
Bioequivalence and Bioavailability Forum |  Admin contact
18,882 posts in 4,026 threads, 1,271 registered users;
online 26 (0 registered, 26 guests [including 25 identified bots]).

Some scientists claim that hydrogen, because it is so plentiful,
is the basic building block of the universe.
I dispute that. I say there is more stupidity than hydrogen,
and that is the basic building block of the universe.    Frank Zappa

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5 RSS Feed