Dataset requirement for UK and EU [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2026-05-18 16:31 (16 d 17:31 ago) – Posting: # 24627
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Hi John,

❝ Can we submit the same format as what is submitted to Canada? Here are what my RA submitted to Canada --> "study-001.dat, study-001.inf, study-001.pkv"

❝ dat concentration, pkv = pk parameters, inf = study information file (i.e, study info, content inside the PKV and DAT). For the Canadian study RA sent in non-xpt file (looks like ASCII LoL) instead of XPT...

I don’t see any reason why not.
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