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Development strategies designed to reduce the unknowns so that cell and gene therapy innovators can develop robust processes ...

It is important to note that E6(R3) is evolving alongside standards like the recently adopted ICH E8(R1), a revision to the General Considerations for Clinical Studies. Indeed, E6(R3) builds ...

Candidates for entry into clinical trials can then be selected based on their effectiveness and safety in disease models. All drugs require data from various toxicological preclinical studies to ...