Excretion >X

Mechanistic Biomarker/Surrogate Clinical Endpoints PD-► Response

Fig. 6.44. Role of Metabolism & Pharmacokinetics body. The ability to correlate drug exposure to effect and model it during the drug development value chain, from mechanistic studies in preclinical models, biomarkers in phase I, surrogate markers in phase II, and clinical end points in phase III, provides valuable insight into optimizing the next steps to derive maximum information from each study. PK/PD analysis and modeling and simulation is becoming increasingly important in drug labeling due to its potential for predicting drug behavior in populations that may be difficult to study in adequate numbers during drug development and due to its value in optimizing clinical trial designs.

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