Ghannam86
☆    

Jordan,
2015-11-24 10:54
(3047 d 04:16 ago)

Posting: # 15659
Views: 5,443
 

 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
(3047 d 02:55 ago)

@ Ghannam86
Posting: # 15660
Views: 4,261
 

 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
22,957 posts in 4,819 threads, 1,638 registered users;
80 visitors (0 registered, 80 guests [including 11 identified bots]).
Forum time: 15:10 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

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