Vienna, Austria,
2022-09-12 12:27
(379 d 05:53 ago)

Posting: # 23293
Views: 2,264

 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.

  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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Helmut Schütz

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India/United Kingdom,
2022-09-16 21:13
(374 d 21:08 ago)

@ Helmut
Posting: # 23302
Views: 1,890


Dear All!
RESOLUTION - RDC NO. 749 -"Provides for exemption from bioequivalence/relative bioavailability studies." has been published.
The main points are:
1. This Resolution provides for the criteria for the exemption of relative bioavailability/bioequivalence studies
2. This Resolution applies to generic, similar, new and innovative medicines
3. In the case of new and innovative medicines, the exemption from relative bioavailability/bioequivalence studies is applicable in the following cases:

I - bioexemption for other concentrations in relation to the concentration for which in vivo bioequivalence has been demonstrated, in cases where the other proposed concentrations are within the approved therapeutic range, understood as the dose range for which data of safety and efficacy and these have been evaluated and approved by the competent federal agency, at the time of registration;

II - bio-exemption based on the biopharmaceutical classification system and due to the pharmaceutical form, route of administration or site of action, in cases of post-registration changes, except for changes related to dosage, expansion of use, inclusion of a new route of administration, new therapeutic indication and inclusion of a new concentration for new drugs, described in the Resolution of the Collegiate Board of Directors - RDC No. 73, of April 7, 2016, or another that may replace it.

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