Bioequivalence and Bioavailability Forum • Pilot BE Report

Pilot BE Report [GxP / QC / QA]

posted by Jay – India, 2013-11-22 09:33 (4592 d 00:46 ago) – Posting: # 11942
Views: 10,674

Dear all,

Regarding Pilot Study do we require to generate the clinical study report in ICH E3 format or for Pilot Study short summarised report is sufficient.

As if regulatory EU or USFDA asks for report one have to provide the same.

Regards,
Jay

Complete thread:

Pilot BE Study balvanth 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 ReportJay 2013-11-22 08:33