HTLEarly LOLate LcT

ID any PK issues

Optimization of animal PK profiles for DC candidates

Projected human effective dose, dose frequency and therapeutic window

ID relevant in vitro or in vivo tools for LO

ADME profiles and potential drug/drug interactions for DC candidates

Anticipated human drug/drug interactions pharmacology model

ID suitable tox species based on relevance of metabolites to humans

PK/PD relationship in pharmacology model

Calculation of preliminary safety margin

Figure 3. DMPK's deliverables at HTL and LO stages

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