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Regard to Clinical Investigators, Form

Regard to Clinical Investigators, Form

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good afternoon everyone my name is shabnam nasier I'm a medical team leader on the division of anti-infectives here at Cedar FDA and today I'll be talking about safety considerations and clinical drug development here are our learning objectives we want to try to understand that protection of subjects comes first um when trying to design early clinical studies and to learn some Key Safety considerations in the conduct of Phase 1 trial and also understand the principles of safety monitoring and Reporting in clinical trials here are the objectives of phase 1 trials we want to assess safety and tolerability of the drug product try to attempt to characterize dose limiting adverse reactions determine the maximum dose that's associated with an acceptable safety profile characterize PK parameters and explore drug metabolism and drug interactions the subjects in Phase One trials uh generally tend to be healthy volunteers that have um less confounding factors because the

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