ANVISA RDC Nº 742 [BE/BA News]
Dear all,
like the EMA the ANVISA required multiple dose studies for MR products. After some discussions1–3 the requirement was lifted. Now only single dose studies are required (except if MD is justified, e.g., in patients under therapy).
PK metrics: \(\small{C_\text{max}}\), \(\small{AUC_{0-\text{t}}}\), \(\small{\textrm{p}AUC_{0-\tau/2}}\), \(\small{\textrm{p}AUC_{\tau/2-\tau}}\).
The guidance4 will be effective with 3 July 2023.
like the EMA the ANVISA required multiple dose studies for MR products. After some discussions1–3 the requirement was lifted. Now only single dose studies are required (except if MD is justified, e.g., in patients under therapy).
PK metrics: \(\small{C_\text{max}}\), \(\small{AUC_{0-\text{t}}}\), \(\small{\textrm{p}AUC_{0-\tau/2}}\), \(\small{\textrm{p}AUC_{\tau/2-\tau}}\).
The guidance4 will be effective with 3 July 2023.
- Schütz H. Steady-State Studies. Presentation at: Estudos em doses múltiplas para medicamentos genéricos e similares de liberação modificada – Contexto nacional e internacional. São Paulo. April 29, 2021. Online.
- Costa Soares KE (Coordenação de Equivalência Terapêutica / ANVISA). Presentation at: Estudos em doses múltiplas para medicamentos genéricos e similares de liberação modificada – Contexto nacional e internacional. São Paulo. April 29, 2021.
- Costa Soares KE, Chiann C, Storpitis S. Assessment of the impact of partial area under the curve in a bioavailability/bioequivalence study on generic prolonged-release formulations. Eur J Pharm Sci. 2022; 171: 106127. doi:10.1016/j.ejps.2022.106127.
- ANVISA. Resolução - RDC Nº 742. Dispõe sobre os critérios para a condução de estudos de biodisponibilidade relativa/bioequivalência (BD/BE) e estudos farmacocinéticos. Brasilia. August 10, 2022. Effective July 3, 2023. Online.
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- ANVISA RDC Nº 742Helmut 2022-09-12 10:27 [BE/BA News]
- ANVISA RDC Nº 749 dshah 2022-09-16 19:13