Single dose PK study on Patients [Design Issues]

posted by Pharma_88 – India, 2024-05-17 12:06 (33 d 00:30 ago) – Posting: # 23998
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Dear Ohlbe,

Thank you for responding. Drug is Olaparib and OGD recommends Two-way crossover Steady State PK study. One of our client wish to conduct single dose BE study as a conventional design without interrupting ongoing treatment of patient. Now whether its a feasible by taking appropriate measures of clinical safety?

Regards,
Pharma_88


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Ohlbe]

Regards,
Pharma_88

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