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RegisterConsult trial design [Design Issues]
Hello everyone, I have two questions. The first question is that I would like to know if ANDA only includes BE studies, and if the endpoints for BE studies can be efficacy endpoints instead of PK parameters.
The second question is about a pediatric anesthetic drug that we have applied NDA in China, and we now want to apply NDA in Europe and the United States. The drug has already been approved for use in adults in Europe and the United States. Can we apply for market approval with just a pediatric bridging study, or we need to collect data from both adults and a small number of children in Europe and the United States and conduct a regular study design? Is there any reference study or paper available?
Thank you very much!
The second question is about a pediatric anesthetic drug that we have applied NDA in China, and we now want to apply NDA in Europe and the United States. The drug has already been approved for use in adults in Europe and the United States. Can we apply for market approval with just a pediatric bridging study, or we need to collect data from both adults and a small number of children in Europe and the United States and conduct a regular study design? Is there any reference study or paper available?
Thank you very much!
Complete thread:
- Consult trial designlibaiyi 2024-07-03 09:12 [Design Issues]
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Ing. Helmut Schütz