Bioequivalence and Bioavailability Forum

Decrease in PSD: Need to repeat BE? [Study Assessment]

posted by qualityassurance – 2024-07-02 10:32 (311 d 15:27 ago) – Posting: # 24052
Views: 2,903

Dear Forum members,

We have conducted a BE study with test product having PSD of X micron API. Now due to patent issue we want to decrease PSD of API to Y micron. Test product is BCS class 3 molecule.
Do we need to conduct BE study again due to change in PSD of API? Our target submission is EMA.

Regards,
QA

Complete thread:

Decrease in PSD: Need to repeat BE?qualityassurance 2024-07-02 08:32 [Study Assessment]
- Type-II Variation Helmut 2024-07-02 09:37
  - Type-II Variation: Waive in-vivo study by providing in-vitro data? qualityassurance 2024-07-02 11:29
    - Type-II Variation: Waive in-vivo study by providing in-vitro data? SMA 2024-07-02 16:27
      - Type-II Variation: Waive in-vivo study by providing in-vitro data? Relaxation 2024-07-04 12:19

Decrease in PSD: Need to repeat BE? [Study As­sess­ment]

Complete thread:

Decrease in PSD: Need to repeat BE? [Study Assessment]