Therapeutic equivalence? [Design Issues]

posted by d_labes  – Berlin, Germany, 2011-02-08 11:37 (5116 d 15:35 ago) – Posting: # 6584
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Dear PK,

what therapeutic action of an Anti-cancer agent do you expect in healthy volunteers :ponder:?

Due to the cytotoxic effects of most Anti-cancer agents it's IMHO unethically to treat healthy volunteers with them. So also a classical BE study (comparing blood/plasma/serum levels is IMHO also not possible in most cases :no:.

Regards,

Detlew

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