Bioequivalence and Bioavailability Forum

Two Versions: May 21 & May 24 [BE/BA News]

posted by Obinoscopy  – USA, 2018-07-29 20:13 (2241 d 10:41 ago) – Posting: # 19114
Views: 8,348

Hi guys,

I noticed there are two versions of the guidance on the internet. One is dated May 21, 2018 while the other is May 24, 2018.

Could it be that the May 24 version is the updated and thus the recommended version to use? Was also wondering what was the modification done .

❝ I kinda like the format with the requirements being tabulated. Easier to find things...

Yea me too. Makes reporting a bit easier for both the CRO and the assessors. Hopefully other NMRAs will follow suit.

Regards,

Complete thread:

• New FDA BMV guideline Ohlbe 2018-05-21 16:28 
  • What a monster! Helmut 2018-05-21 17:47
    • What a monster! jag009 2018-05-24 03:19
      • Two Versions: May 21 & May 24Obinoscopy 2018-07-29 18:13
  • Repeats as part of investigations, ja oder nein? ElMaestro 2018-05-22 00:17
    • Repeats as part of investigations, ja oder nein? Ohlbe 2018-05-22 12:02
      • Two Versions: May 21 & May 24 Obinoscopy 2018-07-30 20:41
        • Requirements ⇒ recommendations Helmut 2018-08-01 11:12
          • Requirements ⇒ recommendations Obinoscopy 2018-08-02 22:59