Posting: # 8154
It's been a while since my last query...so here I am again!
We would like to conduct a BE study in order to file our product in Canada, but we face a dilemma in the BE design. According to the already approved PIL of the Canadian reference product, the drug should be taken by mouth during a meal and with a large glass of water, while in the SmPC it is clearly stated that there are no clinically relevant differences in absorption when the reference product was administered either with food or in the fasting state. Keeping in mind that the Canadian Health Authority recommends BE studies under fed conditions only for specific categories of products (Guidance for Industry: Bioequivalence Requirements: Comparative Bioavailability Studies Conducted in the Fed State (2005)), we were of the opinion of conducting a BE study under fasting condition, while our Canadian CRO was of the opposite opinion. So, can you please share with us your point of view on the design?
Thank you in advance for your assistance!
Edit: Subject line extended, document linked. [Helmut]
(edited by drgunasakaran1 on 2012-02-23 05:33)
Posting: # 8155
The type of studies need to be conducted for Canadian submission will vary depends on the drug molecule you are dealing with.
Category 1. If your drug molecule is a Uncomplicated Immediate Release dosage form;
You need to conduct only fasting study.
However, kindly be informed that if there is a documented serious safety risk to subjects from single-dose administration of the drug or drug product in the absence of food, only fed study is recommended.
Category 2. Complicated Immediate-Release Dosage Forms (narrow therapeutic range drugs, highly toxic drugs and non-linear pharmacokinetics drugs
You need to conduct both fasting and fed studies.
Category 3. Modified Release Drugs
You need to conduct both Fasting and Fed studies
However, be informed that for drugs in category 2 & 3, if there is a documented serious safety risk to subjects from single-dose administration of the drug or drug product in the presence of food or absence of food, only fasting study or only fed study respectively is recommended.
Hence, the study design (Fast and/or Fed study) depends on which category your drug fits into.
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