Vishal S
☆    

India,
2022-05-16 16:40
(681 d 22:54 ago)

Posting: # 22989
Views: 1,291
 

 Bioequivalence study of sertraline HCL capsule [Regulatives / Guidelines]

Dear sir

for Bioequivalence study of sertraline HCL capsule kindly suggest the strength for BE study for ANDA application in US
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2022-05-16 17:48
(681 d 21:46 ago)

@ Vishal S
Posting: # 22991
Views: 1,184
 

 Do your homework first

Hi Vishal,

❝ Dear sir


the forum is not a gentlemen’s club. No interested in madams’ opinions?

❝ for Bioequivalence study of sertraline HCL capsule kindly suggest the strength for BE study for ANDA application in US


See this post #3. Did you miss Guidelines in the menu bar?
What about that one for tablets? Both 150 and 200 mg capsules are RLDs, where the 200 mg strength is the Reference Standard.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,639 registered users;
85 visitors (0 registered, 85 guests [including 8 identified bots]).
Forum time: 14:35 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