Bioequivalence and Bioavailability Forum • Pre-pilot batches for pilot bridging BA/BE studies

Pre-pilot batches for pilot bridging BA/BE studies [Design Issues]

posted by lsilva – Portugal, 2012-10-08 19:20 (5012 d 19:26 ago) – Posting: # 9338
Views: 5,128

Dear all:

Is it possible to use pre-pilot batches manufactured under GMP conditions in pilot bridging BA/BE studies and only pilot batches on the pivotal BD/BE study?

Best regards

Complete thread:

Pre-pilot batches for pilot bridging BA/BE studieslsilva 2012-10-08 17:20
- Pre-pilot batches for pilot bridging BA/BE studies jag009 2012-10-08 18:08
  - Pre-pilot batches for pilot bridging BA/BE studies lsilva 2012-10-08 18:32
    - Pre-pilot batches for pilot bridging BA/BE studies Dr_Dan 2012-10-09 11:36
      - Pre-pilot batches for pilot bridging BA/BE studies lsilva 2012-10-09 11:53