Bioequivalence and Bioavailability Forum

ANVISA: MD studies no more required [Regulatives / Guidelines]

posted by Helmut  – Vienna, Austria, 2022-07-13 19:03 (1098 d 18:21 ago) – Posting: # 23144
Views: 6,004

Hi Shuanghe,

❝ I remember that you had given some talks about BE to ANVISA staff before.

Twice – the last one dealing with the necessity of multiple dose studies.
Haha, now I can write it esp. for you: See this article. If you are short in time, go straight to its Postscript.
Even shorter executive summary (for the guy in the Armani suit): Multiple dose studies are no more required for the ANVISA.
In April 2021 a revision of the guideline was promised for the next summer. If there is one, I failed to find it at the ANVISA’s website, as usual.*

❝ Maybe next time you can suggest why they should not request schedule time point

Sure.

---

• Edit: RDC Nº 742 of 10 August 2022 was published on 18 August 2022 and will be effective with 3 July 2023.
  PK metrics: \(\small{C_\text{max}}\), \(\small{AUC_{0-\text{t}}}\), \(\small{\textrm{p}AUC_{0-\tau/2}}\), \(\small{\textrm{p}AUC_{\tau/2-\tau}}\).

—
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Helmut Schütz


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Complete thread:

• schedule time vs. actual time for AN­VI­SA BE Shuanghe 2022-07-10 00:36 [Regulatives / Guidelines] 
  • schedule time for ANVISA? Helmut 2022-07-10 15:37
  • schedule time vs. actual time for ANVISA BE Relaxation 2022-07-12 13:50
    • Not even wrong Helmut 2022-07-12 16:15
      • Not even wrong Shuanghe 2022-07-13 15:23
        • ANVISA: MD studies no more requiredHelmut 2022-07-13 17:03
    • Relatorio estatistico Ohlbe 2022-07-13 10:23
      • Relatorio estatistico Helmut 2022-07-13 11:02
        • ANVISA Ohlbe 2022-07-13 12:37
          • ANVISA Helmut 2022-07-13 17:17
        • Relatorio estatistico pjs 2022-07-25 10:42
          • Full book? Helmut 2022-07-25 12:32
    • schedule time vs. actual time for ANVISA BE Shuanghe 2022-07-13 15:21
  • schedule time vs. actual time for ANVISA BE ElMaestro 2022-07-12 23:10
    • TPD? Helmut 2022-07-12 23:29
      • TPD? ElMaestro 2022-07-12 23:32
        • TPD! Helmut 2022-07-12 23:55
    • schedule time vs. actual time for ANVISA BE Shuanghe 2022-07-13 15:15
      • schedule time vs. actual time for ANVISA BE ElMaestro 2022-07-14 14:57