Bioequivalence and Bioavailability Forum

What a monster! [BE/BA News]

posted by Helmut  – Vienna, Austria, 2018-05-21 19:47 (2159 d 21:27 ago) – Posting: # 18796
Views: 8,737

Hi Ohlbe,

THX! What a monster!
At least replaced “Concentrations below the LLOQ should be reported as zeros.” in the 2013 draft by “Study samples with concentrations listed below the LLOQ should be reported as below the LLOQ (BQL).” Someone was quick enough responding within the 90 (!) days consultation period…
Looked over the fence and realised that is a good idea to assess carryover. Still the whacky recovery…

❝ Strange, considering that the ICH M10 guideline is on its way. I somehow thought that the FDA guideline had been put on hold.

Politics strategy to strengthen the position in the upcoming negotiations? Better to have a final guidance instead of only the 2013 draft (mentioned in the ICH’s concept paper).

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

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 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 24 Obinoscopy 2018-07-30 20:41
        • Requirements ⇒ recommendations Helmut 2018-08-01 11:12
          • Requirements ⇒ recommendations Obinoscopy 2018-08-02 22:59