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Dear all
We have one doubt about BE study. In fixed dose combinations, can we
take test and reference products with unequal strengths. i.e if drug
A + B+C+D is FDC, comparing with individual reference.
My doubt is,
1. Do test and reference are the same strength or it may be different
(i.e Test A (150 mg) + B (200 mg) + C (100 mg) + D (500 mg) and
Reference drugs have A (150 mg), B (500 mg), C (250 mg), D (600 mg)
2. I have seen one paper on Anti TB FDC drugs, ther they have taken.
Is it correct.
regards,
E.Srinivasa Reddy,
Research Analyst
Pharmacokinetics and Statistics Department
Bioserve Clinical Research Pvt.Ltd
Balanagar, Hyderabad, AP, India
email: esreddy.-a-.bioserve.co.in
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Dear Reddy,
You can not compare these type of FDC under BE criteria.
Nevertheless if you want then only those drugs in FDC which have same
strength can be proved bioequivalent.
e.g. in your example only A can be prooved bio-equivalent.
HIren Mehta
Cadila
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Dear Mr. Reddy,
If you are talking about anti Tb drugs there is an WHO guideline from
1999 which recommends FDC against loose formulations.
You could combine loose formulations till get the same strength than
your product. But then I have a question: Which formulation should
be the reference product?
I have already read the same article on anti TB drugs and I was not
comfortable with half tablets for Bioequivalence studies. I believe
most of the pharmaceutical would agree that this procedure is not
precise.
The other possibility would be looking for a international reference
on the same strength. Again if you are working on anti TB FDC, there
are studies which point out FDC formulations that are not the same
than WHO.
There is an article from India on the use of FDC as reference drugs.
This may be useful.
If there a way to compare different strength on BD studies, please
let me know, I would be very glad.
best wishes,
Andre.
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