正电子发射断层扫描（PET）分子成像探针的研究性新药申请——一所学术机构的方法

INDs for PET molecular imaging probes-approach by an academic institution.

作者信息

Mosessian Sherly, Duarte-Vogel Sandra M, Stout David B, Roos Kenneth P, Lawson Gregory W, Jordan Maria C, Ogden Amanda, Matter Cheryl, Sadeghi Saman, Mills George Q, Schelbert Heinrich R, Radu Caius G, Czernin Johannes, Couto Marcelo, Phelps Michael E

机构信息

Department of Molecular and Medical Pharmacology, David Geffen School of Medicine at University of California Los Angeles, 650 Charles E. Young Dr. South, CHS 23-148, Los Angeles, CA, 90095, USA,

出版信息

Mol Imaging Biol. 2014 Aug;16(4):441-8. doi: 10.1007/s11307-014-0735-2.

We have developed an efficient, streamlined, cost-effective approach to obtain Investigational New Drug (IND) approvals from the Food and Drug Administration (FDA) for positron emission tomography (PET) imaging probes (while the FDA uses the terminology PET drugs, we are using "PET imaging probes," "PET probes," or "probes" as the descriptive terms). The required application and supporting data for the INDs were collected in a collaborative effort involving appropriate scientific disciplines. This path to INDs was successfully used to translate three [(18) F]fluoro-arabinofuranosylcytosine (FAC) analog PET probes to phase 1 clinical trials. In doing this, a mechanism has been established to fulfill the FDA regulatory requirements for translating promising PET imaging probes from preclinical research into human clinical trials in an efficient and cost-effective manner.

我们已经开发出一种高效、精简且具有成本效益的方法，用于从美国食品药品监督管理局（FDA）获得正电子发射断层扫描（PET）成像探针的研究性新药（IND）批准（虽然FDA使用“PET药物”这一术语，但我们使用“PET成像探针”“PET探针”或“探针”作为描述性术语）。IND所需的申请和支持数据是通过涉及适当科学学科的合作努力收集的。这条IND途径已成功用于将三种[（18）F]氟代阿拉伯糖基胞嘧啶（FAC）类似物PET探针转化为1期临床试验。在此过程中，已经建立了一种机制，以有效且具有成本效益的方式满足FDA将有前景的PET成像探针从临床前研究转化为人体临床试验的监管要求。