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Dear all
If I want to perform Bioequivalence study (BE) of 800mg tablet but no reference product is available in market where I want to launch the product can I administer two 400mg tablets at a time as reference product in the study?
If no reference product (of 800mg) is available in European market but available in US market, can I use the US market tablet as reference for a BE study to be submitted to EMEA.
If the dose 800mg is not launched in European market before, what Phases of clinical trials are necessary to perform or only BE can do?
Thanks in anticipation
-- Regards
Rajendra H. Dhande.
Research Student,
Department of Pharmacology and Toxicology,
Bombay College of Pharmacy, Kalina,
Santacruz (E),
Mumbai-400098
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Dear Dhande,
You can take the 800 mg product from USA for BE studies.
Dr zafar
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Hello,
I do not really think that asking a public discussion list for advice on this type of issue is a good idea - what you will get is nothing more that hearsay in effect. This is a question about a regulatory decision that could cost several hundred thousand dollars - which might be all for nothing. The EMEA wont take any notice of "advice" given here. If it were me I would contact the EMEA, or even search its web site, for guidance. I know that if I were an investor in your product I would not be happy with your decision to ask for advice on this board [which is a good resource for many many other things of course David :-)]
Kind regards,
David
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Dear Rajendra,
You can conduct a BE study either 400 mgx 2 tablets or 800 mg tablet. However according to my experiences, I can strongly advice to be careful about the formulations. (The formulation of reference tablets can be different in different markets which may cause some problems during the study. ) Best regards;
Hatice Atkaya, Pharm
Regulatory Science Manager
Turkey
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David: Advice, especially of the "free sort" expands consideration. It does not need to be acted upon but helps to formulate and expand a knowledge base. Taken with advice and suggestions from the regulatory agencies, free advice will provide more bang for the buck, as we say.
Investors are working at the cheap end of things anyway when most of the work has been subsidized by governments, universities and students, Why on earth would an investor worry about researchers being more circumspect?
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Hello Edward,
I agree, free advice, when take for just that, is useful food for though. But then again one gets what one pays for.
I have no doubt that regulatory authorities globally grapple with being presented BE studies using OS comparators (despite a local one being available) using multiple units (despite a single tablet being available locally, but not in the Sponsors "home" country) and permutations of the two. A very messy situation that is only getting worse as generics expand and minimizations of expenditure occur via submissions of common datasets.
A simple phone call or letter to the appropriate authority (or even just reading the guidance documents that are freely available online) would be just as easy as a posting here, and certainly "safer" IMHO.
Regards,
David
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