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Dear all,
I need a clarification on the following.
1. What should be the minimum quantity of the TEST [Investigational
Product] substance manufactured [Batch size] to carry out
Bioequivalence or
compare the Bioavailability Profile with that of a REFERENCE product?
2. Will the TEST [Investigational Product] substance be eligible for
carrying out Bioequivalence [or comparative Bioavailability] study if
there
is a significant difference [of more than 5%] between the assay
values of
the TEST and the REFERENCE substances?
3. Can the Sponsor carry out complete dissolution and assay [and other
analytical tests] tests of the REFERENCE drug and issue a Certificate of
Testing/Analysis on behalf of the Innovator?
Eager to know about the above.
Warm regards,
Prasanna Gudi
Research Associate & Pharmacist
Clinigene, Bangalore
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DEAR PRASSANA
FIND THE RESPONSES IN UPPER CASE:
1. What should be the minimum quantity of the TEST [Investigational
Product] substance manufactured [Batch size] to carry out
Bioequivalence or
compare the Bioavailability Profile with that of a REFERENCE product?
IF YOU TALKING ABOUT US-FDA SUBMISSION , THEN THE MINIMUM BATCH SIZE
FOR PRODUCTION SHOULD NOT BE LESS THAN 1 LAKH TABLETS OR CAPSULES.
THIS IS CALLED AS EXHIBIT BATCH.
2. Will the TEST [Investigational Product] substance be eligible for
carrying out Bioequivalence [or comparative Bioavailability] study
if there is a significant difference [of more than 5%] between the
assay values of the TEST and the REFERENCE substances?
PRODUCT ARE CONSIDERED FOR THE RELATIVE BA STUDY DEPENDING ON THE
LABEL CLAIM (EQUIMOLAR DOSES) AND NOT ON THE POTENCY OF THE DRUG
SUBSTANCE.
3. Can the Sponsor carry out complete dissolution and assay [and other
analytical tests] tests of the REFERENCE drug and issue a Certificate
of Testing/Analysis on behalf of the Innovator?
YES THE GENERIC MANUFACTURER CAN ISSUE A COA FOR THE INNOVATORS
PRODUCTS. BUT THE MAIN POINT TO BE NOTED IS "THEY CANT ASSIGN
SPECIFICATIONS TO THE PRODUCT"
Regards:
Shaikh Feroz Ibrahim
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Hi,
May I add to Feroz's reply, with inputs from my friends,
1. For more details refer to the SUPAC guidelines (Scale up and post
approval changes).
2. Acc to USFDA, guidence for industry BA/BE for orally administered
drug products general consideration, attachment for study conduct,
point 4, difference of 5 % in drug content between test & reference
is NOT recomended. This guideline very clearly states the
"pharmaceutics" aspects of the study formulation.
3. NO, anyone cannot issue a CoA on the behalf of any one. The
sponsor can test the reference at his / her end. BUT, the test method
(s) used by the sponsor for the analysis of the test & reference
formulation must be GLP compliant.
Cheers
Himanshu
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The following message was posted to: PharmPK
Hi!
I would like to add to answer no. 2 of himanshu that guidelines state
that "difference of more than 5% in drug content between test and
reference is not recommended". So, when the difference is exactly 5%
it may be accetable.
Dr Ashish Mungantiwar
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