An Investigational New Drug (IND) submission is a regulatory application that is submitted to the relevant regulatory authorities, such as the US Food and Drug Administration (FDA), to request permission to conduct clinical trials with an investigational drug. The IND submission is a critical step in the development of a new drug and includes the following components:
- Cover letter: A brief overview of the submission and the request for permission to conduct clinical trials.
- Investigator brochure: A comprehensive document that provides information about the trial and the study drug, including details about the study population, study interventions, and outcome measures.
- Chemical, pharmaceutical, and manufacturing information: Detailed information about the chemical structure, formulation, and manufacturing process of the investigational drug.
- Nonclinical study reports: Results of preclinical studies, including pharmacological, toxicological, and pharmacokinetic studies, that provide evidence of the safety and efficacy of the investigational drug.
- Clinical study protocol: A detailed document that outlines the design, conduct, and management of the clinical trial.
- Statistical analysis plan: A document that outlines the statistical methods that will be used to analyze the trial data, including the sample size, the statistical tests that will be performed, and the criteria for statistical significance.
- Investigator qualifications and responsibilities: Information about the qualifications and responsibilities of the clinical trial investigator(s).
- Informed consent form: A document that is signed by the trial participants or their legally authorized representatives, which explains the purpose, risks, and benefits of the trial, and gives permission for the participant to take part in the trial.
- FDA Form 1571: A standard form that is used to provide information about the sponsor, the trial, and the investigational drug.
The IND submission is reviewed by the FDA, and if approved, the trial can proceed. The IND submission is an important step in the development of a new drug and should be carefully prepared to ensure that the trial is conducted ethically, scientifically valid, and efficiently. The IND submission should be reviewed and approved by the sponsor, the IRB, and other relevant stakeholders before it is submitted to the FDA.
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