ANVISA RDC Nº 742 [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2022-09-12 12:27 (83 d 02:43 ago) – Posting: # 23293
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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.


  1. 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.
  2. 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.
  3. 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.
  4. 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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