Hoffmann-La Roche, Clinical Research and Exploratory Development, Clinical Pharmacology, 340 Kingsland Street, Nutley NJ 07110-1199, USA.
J Clin Pharmacol. 2010 Apr;50(4):380-91. doi: 10.1177/0091270009344987. Epub 2010 Jan 23.
The FDA guidance on exploratory IND studies is intended to enable sponsors to move ahead more efficiently with the development of promising candidates. A survey of PhRMA member companies was conducted in 2007 to obtain a cross-sectional industry perspective on the current and future utility of exploratory IND studies. About 56% of survey responders (9 companies of 16 survey responders) conducted or were planning to conduct clinical studies under exploratory INDs. The majority of microdosing studies are performed to characterize human pharmacokinetics or to examine target organ pharmacokinetics using PET imaging techniques. On the other hand, the majority of pharmacological end point studies conducted under exploratory IND are performed to determine whether the compound modulated its pharmacological target or to evaluate the degree of saturation of a target receptor. The present survey suggests that although the merits of exploratory INDs are still being debated, the diversity in the applications cited, the potential for early clinical guidance in decision making and the increasing pressure on containing drug development costs, suggest that the exploratory IND/CTA will be a valuable option with evolving and possibly more specific applications for the future.
美国食品和药物管理局（FDA）关于探索性 IND 研究的指南旨在使赞助商能够更有效地推进有前途的候选药物的开发。2007 年，对 PhRMA 成员公司进行了一项调查，以从当前和未来的角度获得行业对探索性 IND 研究的看法。大约 56%的调查回应者（16 家回应者中的 9 家）正在或计划根据探索性 IND 进行临床研究。大多数微剂量研究旨在描述人体药代动力学或使用 PET 成像技术研究目标器官药代动力学。另一方面，在探索性 IND 下进行的大多数药理终点研究是为了确定化合物是否调节其药理靶点，或评估靶受体的饱和度。本调查表明，尽管探索性 IND 的优点仍在争论之中，但所引用的应用的多样性、在决策中提供早期临床指导的潜力以及控制药物开发成本的压力越来越大，表明探索性 IND/CTA 将是一种有价值的选择，未来可能会有更多具体的应用。
