Bioequivalence and Bioavailability Forum • FDA Supac guidance for ER

FDA Supac guidance for ER [Regulatives / Guidelines]

posted by jag009 – NJ, 2018-09-07 22:31 (2056 d 16:57 ago) – Posting: # 19251
Views: 2,166

Hi,

Question. To support SUPAC (post approval manufacturing site change) filing for ER products, do we need to perform multimedia dissolution testings?

Thanks
John

Complete thread:

FDA Supac guidance for ERjag009 2018-09-07 20:31
- FDA Supac guidance for ER Helmut 2018-09-09 14:04
  - FDA Supac guidance for ER jag009 2018-09-10 18:38

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