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When do I need to do ADME & Drug-Drug Interaction studies?
How is my drug cleared?
What test systems are needed for my in-house DMPK studies?
What nonclinical ADME / DDI studies do I need for a successful IND / NDA?
How can I make sure my data meets regulatory expectations?
I have my ADME / DMPK data… Now what?
How can I mitigate my risk of late-stage failure?
The FDA has requested follow-up data… How do I fill in the gaps?
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In Vitro Drug Metabolism & DDI
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Enzyme Inhibition
Enzyme Induction
Drug Transporters
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Pharmacology & Receptor Binding
Microsomal & Plasma Protein Binding
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Radiolabeled Compound Synthesis (RI)
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In vivo PK Studies
Plasma Protein Binding
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Small Molecule Bioanalysis
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Human Hepatocytes
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