Bioequivalence and Bioavailability Forum

Revisions of the PSGLs final [BE/BA News]

posted by Helmut  – Vienna, Austria, 2023-06-23 15:29 (753 d 18:17 ago) – Posting: # 23612
Views: 9,502

Hi ElMaestro & all,

❝ ❝ Is this really the intention? The wider the range in t_max, the more easily products will pass. Counterintuitive.

❝ The intention, as I understand it, was exactly the opposite. It goes completely against all intention, doesn't it?

❝ I think this knowledge, if it holds in confirmatory simulations, should be published quickly and made available to regulators.

❝ I very much hope that regulators will abstain completely from letting pride prevail over the regard for the EU patient. So I hope they will not dismiss the argumentation. For example, I could fear they would dismiss your findings because they don't have a palate for simulations (but note they like simulations well enough when it comes to f2; bootstrapping is a simulation, too).

Final revisons of the PSGLs were published yesterday.

• Ibuprofen (overview of comments)
  
• Paracetamol (overview of comments)
  
• Tadalafil (overview of comments)

Practically all comments/suggestions were  ignored  not accepted. The only relevant change is 80.00–125.00% of the reference’s median (from 80.00–120.00%). Good luck in sampling every five minutes. 

—
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:

• EMA: New product-specific guidances Helmut 2022-04-08 15:17 
  • How would you implement it? ElMaestro 2022-04-09 11:45
    • Confuse a Cat Inc. Helmut 2022-04-09 18:40
      • Confuse a Cat Inc. ElMaestro 2022-04-09 21:47
        • Confuse a Cat Inc. Ohlbe 2022-04-11 11:29
          • Confuse a Cat Inc. Helmut 2022-04-11 13:59
            • Range Ohlbe 2022-04-11 15:48
              • Range Helmut 2022-04-11 16:07
                • Range Ohlbe 2022-04-11 16:20
              • Range Helmut 2022-07-28 14:43
        • So many questions, so few answers Helmut 2022-04-11 13:03
        • Preliminary simulations Helmut 2022-04-30 14:59
          • Preliminary simulations ElMaestro 2022-04-30 19:10
            • Preliminary simulations Helmut 2022-05-01 15:56
            • Revisions of the PSGLs finalHelmut 2023-06-23 13:29
              • Revisions of the PSGLs final dshah 2023-06-28 14:43
                • EMA: No problems with many sampling time points… Helmut 2023-06-28 15:59
                • New simulations & some desultory thoughts Helmut 2023-06-29 11:34
                  • SCNR. A heretic alternative. Helmut 2023-06-30 11:50
        • Simulated distributions Helmut 2022-05-02 13:43