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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?
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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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