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What is in vitro ADME Study?

• PPB(plasma protein-binding):3 concentrations (including effective concentrations),N=3, focusing on concentration dependence and species differences.

• Metabolic stability/MetID (in vitro metabolism): Metabolic stability/ METID (in vitro metabolism): Focuses on species differences to provide a reference for PK/PD/Tox species selection in vivo

• CYP inhibition (P450 inhibition): IC50 or Ki, 1A2,2B6,2C8,2C9,2C19, 2D6,3A4

• CYP induction (P450 induction): human hepatocytes from 3 donors, mRNA expression and/or enzyme activity changes:1A2, 2B6, 3A4 (refer to FDA Guidances: DD2006 Draft and 2020 In vitro DDI for data analysis)

• Reaction phenotyping: Identification of CYP/Non-CYP metabolic pathways

• Caco-2: In vitro absorption model

• Transporter substrate assessment & inhibition (Transporter study):

  (1) P-gp, BCRP

  (2) Liver transporters (OATP1B1, OATP1B3)

  (3) Kidney transporters (OAT1, POAT3, OCT2, MATE1, MATE2-K)