Estimation of Human Starting Dose for Phase I Clinical Programs

This chapter contains sections titled: Introduction Characteristics of Well-Behaved Therapeutic Candidates Regulatory Guidances for FIH-Enabling Nonclinical Safety Assessment: General Principles Nonclinical Pharmacokinetics and Pharmacodynamics for Human Dose Projection Establishing the First-in-Human Dose Phase I Clinical Trial Support: Use of the MABEL or Pharmacologically Active Dose Support of Exploratory Clinical Studies Considerations in the Design of Phase I Trials Interdisciplinary Partnerships Beyond the FIH Dose Concluding Perspective Four Case Studies References