Dasatinib tablets [Dissolution / BCS / IVIVC]

posted by d_labes  – Berlin, Germany, 2015-11-24 12:14 (3858 d 16:13 ago) – Posting: # 15660
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Dear Ghannam86,

❝ .... In addition, can anybody advise what is the best bioequivalence study design for this product.


Sometimes it may help to use the search facility of this forum :yes:. Right upper corner.

EMA: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/12/WC500179395.pdf
FDA: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm224205.pdf
—
Regards,

Detlew

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