In India there is no requirement of proving BE study. Dissolution studies are sufficient. Should there be strict implementations of BE studies be made for registration of ANDA for marketing in India?
BE studies are not a magic guarantee but it has sense to do it (with few exceptions) with all ANDA, as well as at any other time the manufacturing conditions change critically. A special warning should be taken with the election of the reference compound, typically the originator available in the country, because that version may have not proven BE with the version used in the safety and efficacy clinical trials. What it’s difficult to understand is the enforcement of BE studies after generics has been several years in the market as happen in some countries, I like to call these retrospective BE trials or retrospective clinical QA which sounds amusing.
In India, as per regulatory norms, BE studies may be required in the case of subsequent generic versions of an approved new drug (oral formulation) if it falls within a period of four years of launch of the first product.
Further, BE studies may pose another dilemma - 'which reference drug?', if several products containing the approved drug are already in the market.
Finally, in addition to 'pharmaceutical equivalence", it is advisable to do "in vitro - in vivo correlation" based on in vitro dissolution and bio-equivalence study data.
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