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Is it mandatory to do ADME radiolabelled phase I before Phase II studies?

April 26, 2017ADME ii mandatory phase phase i

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Is it mandatory to do ADME radiolabelled phase I before Phase II studies?

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Absolutely NOT. As you could imagine the ADME Phase I is an expensive study. People will not spend that kind of money unless they see some promise in the compound being developed. Thus, Phase I ADME study is generally conducted post-Phase II study or in parallel to Phase III study.