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Questions and Answers
When will the drug’s sponsor file an Investigational New Drug (IND) Application with the FDA?
When will the drug’s sponsor file an Investigational New Drug (IND) Application with the FDA?
- Only if the drug shows promise in Phase 3 human trials
- Before the preclinical studies demonstrate adequate safety
- After the drug demonstrates adequate safety in preclinical studies (correct)
- After Phase 1 human studies demonstrate safety and efficacy
What is the purpose of progressive human trials through Phases 2 and 3?
What is the purpose of progressive human trials through Phases 2 and 3?
- To design labeling and packaging
- To develop manufacturing scale-up and process controls
- To define the agent’s basic and clinical pharmacology
- To assess safety and efficacy (correct)
What continues as the clinical trials progress through Phases 2 and 3?
What continues as the clinical trials progress through Phases 2 and 3?
- Preclinical studies to assess safety
- Proposed labeling and package design
- Product design and development
- Laboratory work toward defining the agent’s basic and clinical pharmacology (correct)
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