OT: BW in ANCOVA [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2019-06-18 13:39  – Posting: # 20335
Views: 877

Hi ElMaestro,

» I believe they meant to do an ANCOVA with total dose as covariate.

So do I.

At the 2nd GBHI conference (Rockville 2016) body weight as a covariate was a hot topic. Body weight changes quite often in studies of anti-cancer drugs. The FDA was happy with that. No way for the EMA – as usual.

Cheers,
Helmut Schütz
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