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As per new guidelines on dissolution and BE requirements for EU
countries; Dissolution profile of Generic product should be mapped to
Innovator products at least in three media i.e.- 1.2, 4.5 and 6.8 pH
along with BE requirements.
My queries are following:
1. Do we require to prove multimedia dissolution matching of generic
product with innovator product (F2 values > 50 through out pH range),
even though generic product is proven bioequivalent to RLD of
innovator, and F2 Values for all other strengths are well above 50,
when compared to generic bio strength (as per requirement for bio-
waiver to non RLD strengths) ?
What are the scientific basis for this type of exercise in case of
drugs with absence of IVIVC ?
How are regulatory agencies accepting the situation, where it is very
difficult for generic product to mimic innovator dissolution profile
through out pH range; although it may have proven bioequivalent.
2. Secondly how strict is the requirement to chose pH 1.2 , 4.5 and
6.8 ? Can we vary like pH 2.1, 5.0 and 7.2 or like that.
3. What are the response of agencies in case 6.8 is replaced by
purified water (though it is not buffered, but in case it is accepted
in US as OGD media) ?
Thanks & Regards,
Vivek M K Dubey
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