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I have a query regarding adminstration of glucose solution during conducting of bioequivalence study of antidiabetic drugs. As per draft guidance of USFDA we should administer 60ml of water (containing 20% glucose solution) every 15 min till 4 hours to prevent hypoglycemia.
For the conducting of BE study for European countries any EMEA guidalines given to administer glucose solution in order to prevent hypoglycemia in healthy volunteers. Is it mandatory to give glucose solution irrespective of any regulatory guidelines.
can you give me any information regarding this issue.
With best regards,
Jagan Mohan k. BA/BE Department Genovo Development Services Limited (a Medreich Group Company)
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The following message was posted to: PharmPK
Dear Jagan!
The difference between FDA and EMA is that FDA has published - besides the general guidances - 822 product specific guidances. Your study design should be based on science first. Do you really think that EMA wants you to risk hypoglycaemic episodes in your study, just because nothing specifically to prevent them is stated in the European BE guideline?
BTW, what do you think about following section of the GL (4.1.4 Study conduct, Standardisation): "In rare cases, the use of a concomitant medication is needed for all subjects for safety or tolerability reasons (e.g. opioid antagonists, anti-emetics)."
Rose is a rose is a rose is a rose (Gertrude Stein)
Guidelines are guidelines are guidelines (Henrike Potthast, German BfArM)
Regards,
Helmut
-
Ing. Helmut Schuetz
BEBAC - Consultancy Services for
Bioequivalence and Bioavailability Studies
Neubaugasse 36/11
1070 Vienna, Austria
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