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

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: $$\small{C_\text{max}}$$, $$\small{AUC_{0-\text{t}}}$$, $$\small{\textrm{p}AUC_{0-\tau/2}}$$, $$\small{\textrm{p}AUC_{\tau/2-\tau}}$$.

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

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