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Back to the forum  Query: 2017-11-24 13:58 CET (UTC+1h)

Fed VS Fast state in BE studies [Design Issues]

posted by M.tareq - 2017-02-26 09:34  - Posting: # 17110
Views: 1,877

Dear all ,.
question about fed state design and fast one in a modified release drug

due to expected high variability in fed state study we will use partial replicate design,
however there's no expected high variability in fast state (PPI drug)
my question is the design for the fed state should be the same for fast one ? i.e partial replicate ? and the basis for that if yes, mean we are comparing the test in fed state vs ref in fed state and vice versa

N.B according to EMA guidelines

Thanks in advance

best regards

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