Bioequivalence and Bioavailability Forum • Pilot BE Study

Pilot BE Study [GxP / QC / QA]

posted by balvanth – India, 2012-07-09 15:33 (4302 d 06:04 ago) – Posting: # 8909
Views: 11,058
(edited by Jaime_R on 2012-07-17 15:00)

Dear All,

it is necessary to follow GMP during manufacturing finished dosage form for conducting pivotal BE studies.

do we need to manufacture the pilot batch too under GMP conditions for using in the pilot BE study?

what are the guidelines recommends in this regards?

Regards
BKumar
QA, GPR

Edit: Catgory changed. [Jaime]

Complete thread:

Pilot BE Studybalvanth 2012-07-09 13:33
- Pilot BE Study (GMP requirement) Helmut 2012-07-09 16:01
  - Pilot BE Study (GMP requirement) balvanth 2012-07-17 14:01
    - Pilot BE Study (GMP requirement) Ohlbe 2012-07-17 14:49
- Pilot BE Study ElMaestro 2012-07-17 17:56
  - Pilot BE Report Jay 2013-11-22 08:33