Mechanism‐Based Pharmacokinetic–Pharmacodynamic Modeling During Discovery and Early Development

This chapter contains sections titled: Introduction Challenges in Drug Discovery and Development Methodological Aspects and Concepts Use of PK–PD Models in Lead Optimization Use of PK–PD Models in Clinical Candidate Selection Entry-into-Human Preparation and Translational PK–PD Modeling Use of PK–PD Models in Toxicology Study Design and Evaluation Justification of Starting Dose, Calculation of Safety Margins, and Support of Phase I Design Phase I and Beyond Support of Early Formulation Development Outlook and Conclusions References