Deviating from a guidance [Design Issues]

posted by Pharma_88 – India, 2024-05-21 10:32 (29 d 03:16 ago) – Posting: # 24005
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Dear Helmut,

Thank you. Yes for For submission study, will definitely initiate CC with FDA. Since this is a pilot study where main objective is to assess the possibility of the single dose administration effect on pharmacokinetic as well as safety. So any possibility to conduct parallel design study? if yes, how it will be designed?

Regards,
Pharma_88

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