On 8 September 2025, ANVISA announced Guide 80/2025 (v1) on the Utilization of Physiologically Based Biopharmaceutics Modeling (PBBM). The document compiles technical recommendations for model development, validation, and application, plus submission instructions for registration and post-registration of synthetic drugs. The consultation is open until 5 January 2026.
Key elements at a glance:
• When PBBM is acceptable for ANVISA review and who may submit analyses.
• Pre-submission consultation mechanics and communication workflow with ANVISA.
• Documentation requirements and Annex templates (standard report and technical review format).
• Model qualification expectations, including validation datasets, sensitivity analyses, and performance criteria.
• Scenarios where PBBM is most relevant (biowaiver justifications, IVIVR/IVIVC, food-effect assessments, post-approval changes).
• Transparency and reproducibility principles: traceable datasets, clear assumptions, and version control.
Practical impact for sponsors: the guide supports BE and biowaiver rationale, IVIVR/IVIVC, food-effect and formulation bridging, streamlines CMC and biopharmaceutics assessments, and encourages transparent, reproducible modeling consistent with global moves toward MIDD.
InSilicoMinds supports R&D teams with Modeling and Simulation across discovery to generics PBBM/PBPK, virtual BE, Molecular Dynamics, and ADME workflows, with regulatory-grade documentation aligned to the ICH M15 Guideline and Good Simulation Practices (GSP). As Brazil formalizes expectations, this includes gap assessments of existing models against Guide 80/2025, end-to-end PBBM studies from data curation through model qualification, and submission-ready reports per ANVISA’s annexed templates.
ANVISA’s PBBM Guide 80/2025 Link: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2025/anvisa-publica-guia-sobre-modelagem-farmacocinetica-baseada-em-fisiologia
