Bioequivalence studies for GCC submission [Design Issues]
❝ Would it be acceptable to conduct bioequivalence studies for GCC submission at CRO if the facility has already been inspected by the US FDA? We don’t have separate GCC facility approval.
—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
Complete thread:
- Bioequivalence studies for GCC submission professionalr 2025-01-30 23:00 [Design Issues]
- Bioequivalence studies for GCC submissiondrgunasakaran1 2025-01-31 03:20