Bioequivalence Study without approved/marketed or no RLD [Regulatives / Guidelines]

posted by Pharma_88 – India, 2020-03-13 08:37 (502 d 12:30 ago) – Posting: # 21261
Views: 3,142

Hello All,

Greetings!!

We got an inquiry to conduct BE for XYZ molecule but at the time of feasibility we came to know that RLD for XYZ molecule is not approved/marketed in our country. Means there is no RLD.

Still sponsor wants to market their product. In this case, what we can do? Can we do directly PK study or Phase III study of sponsor's product in patients?

Thanks.

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