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Clinical study requirements for an Investigational New Drug (IND) application are designed to ensure the safety and efficacy of the investigational drug during human trials. Here are the key aspects and requirements:
– Clinical Study Protocol
– Informed Consent
– Good Clinical Practice (GCP)
– Safety Reporting
– Institutional Review Board (IRB) Approval
– Clinical Trial Registration
– Data Monitoring Committee (DMC)For details: https://pharmadigests.com/fda-clinical-study-requirements-for-ind/
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