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stugwins

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stugwins

Re: Ville post# 1927

Friday, 11/10/2017 2:51:56 PM

Friday, November 10, 2017 2:51:56 PM

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One relies on PK data to piggy back on data from an originator drug (thus 351k process).

If you don't need bridging studies (i.e. no PK and you follow the 351a pathway) then you need to do full blown phase 1, 2, 3 studies (which Rolontis, to my understanding, is not).

So what is it? 351k or 351a?
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