Bioequivalence and Bioavailability Forum

Reanalysis for PK Reason: Gone with the Wind [Bioanalytics]

posted by Helmut  – Vienna, Austria, 2020-07-16 18:39 (227 d 03:01 ago) – Posting: # 21720
Views: 2,692

Dear Ohlbe,

» » According to the current guidelines (EMA 2011, FDA 2018, ICH draft 2019) it is no more acceptable. IMHO, bad science.
»
» Agreed.

Agreed on what? That is not acceptable or that it is bad science? Don’t feel pushed to answer. 

» Strangely enough, according to discussions I had with people involved in drafting the EMA guideline, it seems that it was the assessors who did not want to hear about PK repeats, not the inspectors…

That’s very strange indeed.

» … – though the latter are well known for their paranoia, and for good reasons.

Of course.

—
Dif-tor heh smusma 🖖
Helmut Schütz


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

Complete thread:

• Reanalysis for Pharmacokinetic Reason Obinoscopy 2020-07-16 14:30 [Bioanalytics] 
  • Reanalysis for PK Reason: Gone with the Wind Helmut 2020-07-16 15:10
    • Reanalysis for PK Reason: Gone with the Wind Ohlbe 2020-07-16 17:16
      • Reanalysis for PK Reason: Gone with the WindHelmut 2020-07-16 18:39
        • Reanalysis for PK Reason: Gone with the Wind Ohlbe 2020-07-16 19:15
      • Reanalysis for PK Reason: Gone with the Wind Obinoscopy 2020-07-16 21:48
        • PK assessors variability Ohlbe 2020-07-16 23:07
          • Sometimes PK assessors ≈ scientists Helmut 2020-07-17 16:11
          • PK assessors variability Obinoscopy 2020-07-17 23:48
        • Reanalysis for PK Reason: Gone with the Wind ElMaestro 2020-07-16 23:19
          • Reanalysis for PK Reason: Gone with the Wind dshah 2020-07-17 06:40
            • Reanalysis for PK Reason: Gone with the Wind Obinoscopy 2020-07-18 00:27
              • Reanalysis for PK Reason: Gone with the Wind dshah 2020-07-20 07:22
                • Reanalysis for PK Reason: Gone with the Wind Obinoscopy 2020-07-20 14:12
                • Positive pre-dose Ohlbe 2020-07-20 14:43
          • Reanalysis for PK Reason: Gone with the Wind Obinoscopy 2020-07-18 00:00
            • Reanalysis for PK Reason: Gone with the Wind ElMaestro 2020-07-20 07:49
              • Reanalysis for PK Reason: Gone with the Wind Helmut 2020-07-20 10:52
                • Sightly OT (for once) ElMaestro 2020-07-20 12:12
  • Reanalysis for Pharmacokinetic Reason Achievwin 2020-07-27 23:47