Bioequivalence and Bioavailability Forum • SUPAC level 3 changes for MR formulations

SUPAC level 3 changes for MR formulations [Regulatives / Guidelines]

posted by Mithu – India, 2019-10-23 09:21 (570 d 06:40 ago) – Posting: # 20716
Views: 1,921

Hi,

» Did you read the SUPAC guidance for IR?

Yes.

» I dont follow. Are you asking if the study should be a fasted study?

Yes. If you see guidance for Food effect, under SUPAC title (for site change), states fasting study is needed and fed generally not needed.

Regards,

Mithu

Complete thread:

SUPAC level 3 changes for MR formulations Mithu 2019-09-30 07:42 [Regulatives / Guidelines]
- SUPAC level 3 changes for MR formulations jag009 2019-10-22 21:31
  - SUPAC level 3 changes for MR formulationsMithu 2019-10-23 09:21
    - SUPAC level 3 changes for MR formulations jag009 2019-10-24 05:34