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DMPK in Small-Molecule Development: Key Regulatory Guidelines for IND/CTA and NDA/MAA
DMPK (drug metabolism and pharmacokinetics) is a core scientific discipline in drug discovery and development, and programs that underinvest in DMPK strategy early often pay for it later. At the discovery stage , the DMPK objective is to optimize key PK parameters (CLpu, Fpo, t1/2, MRT) and balance target-relevant exposure against potency, off-target risk, and drug-drug interaction (DDI) potential to meet the Research Target Profile (RTP), while building PK/PD understanding
Jean-François Lévesque
Dec 30, 2025
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