Áֿ俬±¸ºÐ¾ß | Tailored pharmacotherapy |
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Pharmacokinetic and pharmacodynamic study in relation to pharmacogenetics | |
Pharmacogenetic epidemiology | |
Pharmacogenetics in the drug discovery and development |
Áֿ俬±¸ºÐ¾ß | Drug Metabolism/Pharmacokinetics |
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PharmacoMetabolomics | |
Bioanalysis |
Ç׸ñ | ¿ä¼Ò±â¼ú | |
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In vitro metabolism | Metabolic stability | Metabolic stability in microsomes, hepatocytes, plasma, blood |
Subcellular metabolism | Hepatocytes, S9 fraction, cytosol, microsomes, intestine | |
Metabolic route and kinetics | Reaction phenotyping and kinetics of Phase I (CYPs) and Phase II (UGT) enzymes | |
Interspecies comparative metabolism | Monkey, dog, hamster, mouse, rabbit, rat | |
Metabolite Identification | Metabolite structure ID, toxic metabolite ID | |
In vitro transport | Permeability test |
Permeability in Caco-2, MDCK, LLC-PK1 cells Cryopreserved hepatocytes uptake Biliary excretion in sandwich cultured hepatocytes |
Transport system and kinetics |
Uptake screening test in Xenopus oocytes Efflux screening test in MDCK-MDR1, MRPs, BCRP |
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Pharmacogenetics study | Transport activity in wild type and variant transporters | |
Drug-drug interaction | Inhibition |
Screening of inhibitory potential of CYPs, UGTs, transporters Estimation of IC50 (Ki) value |
Mechanism-based inhibition |
IC50 shift assay, reversibility assay Estimation of KI and kinact value |
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Induction |
Reporter assay mRNA expression level in hepatocytes Phenotyping assay using specific substrates |
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In vivo PK (preclinical) |
Mass balance | Mass balance study using radioactive or non-radioactive compounds |
Absorption | Estimation of bioavailability | |
Distribution |
Tissue distribution (brain, liver, kidney etc) Blood partitioning, Protein binding |
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Metabolic profiling | Metabolites profiling and Met ID | |
Excretion | Renal excretion, biliary excretion, enterohepatic circulation | |
In vivo PK (human) |
Translational Research | In vitro to in vivo extrapolation (SimCYP) |
Interspecies Pharmacokinetic Scaling | ||
Consultation of decision making for further clinical development | ||
Phase 0 study | Microdosing study | |
Phase I study | First in human study | |
Absolute bioavailability | ||
Drug-drug interaction potential study (cocktail study) | ||
Genotype based ADME study | ||
Special population (Gender, nephropathy, hepatic failure, Elderly) | ||
Bridging study |