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Since Donepezil is included in BCS 1, should we perform
bioequivalency test for this drug product?
Thanks in advance.
Best regards,
Siswanto Tanuatmojo
Analytical Research and Development
PT. Interbat
Jl. HR Moch Mangundiprojo no. 1
Buduran, Sidoarjo - 61252
East Java, Indonesia
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Hi Siswanto,
IF intended for FDA submission, go through the BCS based biowaiver
guideline and meet all the criteria to get waiver.
If for EU then I am afraid this will not help, go for BE.
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