raveendra
☆    

2008-03-10 10:52
(6091 d 21:57 ago)

Posting: # 1665
Views: 3,735
 

 replicated study [Regulatives / Guidelines]

Hello sir,

Good afternoon. I have one doubt. can we do the study on replicated design (2 reference, 1 test)? will the regulatories be accepting these type of designs in average bioequivalence? If yes plz suggest me the SAS procedure?

Thank you.
MGR
★    

India,
2008-03-10 11:40
(6091 d 21:09 ago)

@ raveendra
Posting: # 1668
Views: 3,262
 

 replicated study

Hi raveendra,

❝ can we do the study on replicated design (2 reference, 1 test)?


Here you said that 2 references and 1 test if it so then it would not become an Replicated Design (Replicated Design means the test or reference should be repeated). If u want the clarity or about sequences check in the USFDA guideline "Guidance for Industry: Statistical Approaches to Establishing Bioequivalence" in Section V: Point A, subsection 2, Page number 7.

❝ will the regulatories be accepting these type of designs in average bioequivalence?


Generally this type of design is used to see whether which reference drug is more suitable (w.r.t bioequivalence) for the test drug. Sorry I too don't know whether regulatories will accept or not?

❝ If yes plz suggest me the SAS procedure?


And we have to do the analysis w.r.t R1 and w.r.t R2. These are all according to my opinion only.

Thank you.

--
Edit: Standard quotes restored. [Helmut]

Regards,
MGR
UA Flag
Activity
 Admin contact
23,297 posts in 4,892 threads, 1,686 registered users;
76 visitors (0 registered, 76 guests [including 8 identified bots]).
Forum time: 08:49 CET (Europe/Vienna)

Laws are like sausages – it is better
not to see them being made.    Otto von Bismarck

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