Outliers: The FDA follows the EMA [BE/BA News]

posted by jag009  – NJ, 2019-03-06 20:23 (2269 d 11:00 ago) – Posting: # 20002
Views: 3,865

Hi Helmut,

So they effectively killed off the re-dose/re-challenge study then?
I spoke to a colleague earlier this year and he said FDA no longer wants to see re-challenge study...

John

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Pharmacokinetics may be simply defined as
what the body does to the drug,
as opposed to pharmacodynamics, which may be defined as
what the drug does to the body.    Leslie Z. Benet

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