No, sorry [Design Issues]

posted by Ohlbe – France, 2024-05-17 15:45 (30 d 13:37 ago) – Posting: # 23999
Views: 1,238

Dear Pharma_88,

Well, olaparib is to be taken every day, twice a day, and has a terminal half-life of 15 hours. How could you possibly do a single-dose BE in patients, without treatment interruption ? Even if you were to enrol patients requiring treatment and who have not started it yet, and do a 72-hour PK after their first dose: that would mean delaying the next doses, which would trigger some ethical concerns, and you would need to go for parallel design.

Regards
Ohlbe

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