Bioequivalence and Bioavailability Forum

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

posted by Obinoscopy  – USA, 2018-07-30 22:41 (2093 d 17:17 ago) – Posting: # 19117
Views: 7,893

❝ But IS variations could be considered an assignable cause for analytical repeats.

Yes it is, but I think there is need to determine assignable cause for IS variations.

❝ 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 have skimmed through both documents. I did not notice any difference except for a very negligible formatting difference: the May 24 document seemed a bit narrower.

If they are same, I wonder what the FDA did on the document for it to change from a size of 373KB to 386KB. I also wonder why the update if there were no changes made. My pondering continues

Complete thread:

• New FDA BMV guideline Ohlbe 2018-05-21 16:28 [BE/BA News] 
  • What a monster! Helmut 2018-05-21 17:47
    • What a monster! jag009 2018-05-24 03:19
      • Two Versions: May 21 & May 24 Obinoscopy 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 24Obinoscopy 2018-07-30 20:41
        • Requirements ⇒ recommendations Helmut 2018-08-01 11:12
          • Requirements ⇒ recommendations Obinoscopy 2018-08-02 22:59