Bioequivalence and Bioavailability Forum

Dr.Pravin ☆ Ahmedabad, 2006-10-05 11:10 (6412 d 04:15 ago) Posting: # 275 Views: 4,327	Do the Kit (H.Pylori) required BE for Marketing [Design Issues] Post reply
	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
★★★

Vienna, Austria,
2006-10-05 15:44
(6411 d 23:41 ago)

@ Dr.Pravin
Posting: # 277
Views: 3,513

BE for Combination Products

Post reply

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...

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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

BE for Combination Products