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RegisterBioequivalence Study without approved/marketed or no RLD [Regulatives / Guidelines]
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.
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.
Complete thread:
- Bioequivalence Study without approved/marketed or no RLDPharma_88 2020-03-13 08:37 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Bioequivalence Study without approved/marketed or no RLD ping4santosh 2020-03-13 10:01
- BE wo local originator Helmut 2020-03-13 10:51
Ing. Helmut Schütz