End of consultation approaching‼ [Regulatives / Guidelines]

posted by Dr_Dan  – Germany, 2016-01-28 10:27 (3301 d 09:46 ago) – Posting: # 15872
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Hi Helmut and all other
Do you think that we ever get a final version? ;-)
As you know I am not a fan of these product specific bioequivalence guidelines. Interestingly one of the guidances was commented by the originator who requested that additional studies need to be performed and provided information on variability which IMHO are not correct. So we need to carefully evaluate the comments (especially of originators and their straw men) and to make EMA aware not to follow lobbyists.
Kind regards
Dr_Dan

Kind regards and have a nice day
Dr_Dan

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