所有类型的IND应用程序必须在三个广泛的领域中包含信息:
- 药理学和毒理学研究 – from the pre-clinical data to permit an assessment as to whether the product is reasonably safe for initial testing in humans
- 制造信息 – detailing the composition, manufacturer, stability, and controls used for manufacturing the drug substance and the drug product to ensure that the company can adequately produce and supply consistent batches of the drug.
- 临床方案和研究者信息 – for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks. Commitments to obtain informed consent from the research subjects, to obtain review of the study by an institutional review board (IRB,) and to adhere to the investigational new drug regulations.
一旦提交了IND申请,就有30个临床日的等待时间,而FDA则在启动临床研究之前进行安全评估。