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RegisterBioequivalence Study without approved/marketed or no RLD [Regulatives / Guidelines]
Hello,
If the RLD is unavailable in your country (yet to get register), how would the generic market itself? In EU and middle East, the RLD has to be registered in the target market for the generic to get a chance based on BE. It could be different in China.
What I understand from your draft is that you are the CRO. If sponsor gives you the RLD and test article you can go for pK based study.
Cheers, SKM
If the RLD is unavailable in your country (yet to get register), how would the generic market itself? In EU and middle East, the RLD has to be registered in the target market for the generic to get a chance based on BE. It could be different in China.
What I understand from your draft is that you are the CRO. If sponsor gives you the RLD and test article you can go for pK based study.
Cheers, SKM
Complete thread:
- Bioequivalence Study without approved/marketed or no RLD Pharma_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 RLDping4santosh 2020-03-13 10:01
- BE wo local originator Helmut 2020-03-13 10:51
Ing. Helmut Schütz