Ghannam86
☆    

Jordan,
2015-11-24 10:54
(3075 d 08:19 ago)

Posting: # 15659
Views: 5,544
 

 Dasatinib tablets [Dissolution / BCS / IVIVC]

Dear All,

Can anybody here inform if they have dissolution data for dasatinib tablets 140 mg in different buffers. In addition, can anybody advise what is the best bioequivalence study design for this product.

Regards,
d_labes
★★★

Berlin, Germany,
2015-11-24 12:14
(3075 d 06:59 ago)

@ Ghannam86
Posting: # 15660
Views: 4,338
 

 Dasatinib tablets

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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