Bioequivalence and Bioavailability Forum • FDA Supac guidance for ER

FDA Supac guidance for ER [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2018-09-09 16:04 (2421 d 04:48 ago) – Posting: # 19253
Views: 2,358

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!
Helmut Schütz

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

Complete thread:

FDA Supac guidance for ER jag009 2018-09-07 20:31 [Regulatives / Guidelines]
- FDA Supac guidance for ERHelmut 2018-09-09 14:04
  - FDA Supac guidance for ER jag009 2018-09-10 18:38