Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-inHuman (FIH) Trials; Guidance for Industry; Draft Guidance
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- Title
- Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-inHuman (FIH) Trials; Guidance for Industry; Draft Guidance
- Posted
- Jun 24, 2026
- Comment period
- Jun 24, 2026 – Jul 25, 2026
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- Jul 24, 2026Comment from Biotechnology Innovation Organization (BIO)Analysis pending📎 AttachmentRead comment →
- Jul 24, 2026Comment from Biotechnology Innovation OrganizationAnalysis pending📎 AttachmentRead comment →
- Jul 23, 2026Comment from CertaraSupportBusiness📎 Attachment
Certara expresses strong support for the draft guidance on QSP-based dose selection for MABEL in FIH trials. They propose specific refinements to improve clarity, model complexity definitions, and alignment with existing FDA frameworks like NAMs and MIDD.
Read comment → - Jul 22, 2026Comment from American Association of Pharmaceutical Scientists (AAPS)SupportTrade association📎 Attachment
The American Association of Pharmaceutical Scientists provides detailed feedback on the draft guidance for QSP-based dose selection in FIH trials. They support the guidance but recommend specific revisions to clarify definitions of biological effects, model complexity, validation approaches, and reproducibility requirements for submitted code.
Read comment → - Jul 6, 2026Comment from Natalie MaOtherIndividualRead comment →
- Jul 3, 2026Comment from PharmetheusAnalysis pending📎 AttachmentRead comment →