Table 1.
Translational medicine, including studies focused on interrogation/evaluation of mechanism‐of‐action, human physiology, and interruption of disease pathophysiology |
Hypothesis generating nonclinical and clinical studies, including small clinical trials |
Models of human disease and their therapeutic implications |
Studies that guide Phase 2 dose selection |
Studies that identify or support biomarkers that can be used at any stage of drug development |
Studies that demonstrate effective communication between basic and clinical science |
Regulatory and public health policy implications of translational studies |
Pharmacokinetic/pharmacodynamic (PK/PD) and quantitative pharmacology as these relate to translational medicine |
Precision medicine |