Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
June 24, 2026
June 22, 2026
994ae4f9-15eb-4cb0-9f01-39f7e22daee5
Related Documents
Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing
Guidance DocumentSeptember 2, 2026Center for Drug Evaluation and Research
Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products: Draft Guidance for Industry
Guidance DocumentJanuary 9, 2026Center for Drug Evaluation and Research
Clinical Pharmacology Considerations for Peptide Drug Products
Guidance DocumentDecember 14, 2023Center for Drug Evaluation and Research
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust KeyPedia for their regulatory compliance needs.