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raveendra ☆ 2008-03-10 10:52 (6659 d 20:15 ago) Posting: # 1665 Views: 5,056 |
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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. |
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MGR ★ India, 2008-03-10 11:40 (6659 d 19:26 ago) @ raveendra Posting: # 1668 Views: 4,373 |
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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 |
Ing. Helmut Schütz