Ghannam86
☆    

Jordan,
2015-11-24 10:54
(3866 d 04:32 ago)

Posting: # 15659
Views: 7,491
 

 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
(3866 d 03:11 ago)

@ Ghannam86
Posting: # 15660
Views: 5,810
 

 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
UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,571 registered users;
127 visitors (0 registered, 127 guests [including 14 identified bots]).
Forum time: 16:26 CEST (Europe/Vienna)

The great tragedy of Science – the slaying
of a beautiful hypothesis by an ugly fact.    Thomas Henry Huxley

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5