Dr.Pravin
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Ahmedabad,
2006-10-05 11:10
(7191 d 09:06 ago)

Posting: # 275
Views: 6,832
 

 Do the Kit (H.Pylori) required BE for Marketing [Design Issues]

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I want to know about the Kit required BE Study or not?

Think H.Pylori Kit (Lansoprazole + Clarithromycin + Tinidazole Combination)
so there is any guidline which specify the same.
—
Dr.Pravin Ahir
Co-Investigator,
Accutest Research Pvt.Lab.(I), Ltd.
Ahmedabad
 
Helmut
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Vienna, Austria,
2006-10-05 15:44
(7191 d 04:32 ago)

@ Dr.Pravin
Posting: # 277
Views: 5,297
 

 BE for Combination Products

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Hello Dr. Pravin!

Since at least gastric resistant lansoprazole is not a candidate for a biowaiver, following rules apply:
  • If the combination is already marketed in the country you are aiming for application, you should demonstrate (in vivo-) BE to the reference kit (first approved product).
  • If the combination is not yet marketed, you must demonstrate BE to a combination of the three single API products.
You should consult the Guidance page for specific informations.

Be prepared for a large sample size in a conventional 2×2 design or a replicate design study, since lansoprazole is a HVD...
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