Uppoor R S, Mummaneni P, Cooper E, Pien H H, Sorensen A G, Collins J, Mehta M U, Yasuda S U
Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Clin Pharmacol Ther. 2008 Jul;84(1):69-74. doi: 10.1038/sj.clpt.6100422. Epub 2007 Nov 21.
The aim of the study was to evaluate the use of imaging in the development of neuropharmacological drugs. All New Drug Applications (NDAs) approved from 1995 through 2004 in the Division of Neuropharmacological Drug Products at the Food and Drug Administration were surveyed for imaging studies. Imaging literature was also reviewed with respect to antipsychotics and antidepressants. One hundred and six NDAs (35 new molecular entities (NMEs)) were approved; 15 of these NDAs (10 NMEs) had imaging studies. The primary imaging modality was positron emission tomography. Imaging was primarily conducted for drugs used in schizophrenia, depression, multiple sclerosis, and migraine. The majority evaluated receptor occupancy or proof of concept. Examples (including literature) are discussed as pertinent to dosage, efficacy, safety, or further development of a drug or class of drugs. Imaging contributes to optimal clinical development of central nervous system (CNS)-active drugs. Opportunities are available for its broader use, contributing to improved understanding of the clinical pharmacology of CNS-active drugs.
本研究的目的是评估成像技术在神经药理学药物研发中的应用。对1995年至2004年期间美国食品药品监督管理局神经药理学药品部门批准的所有新药申请（NDA）进行了成像研究调查。还针对抗精神病药和抗抑郁药对成像文献进行了综述。共批准了106份新药申请（35种新分子实体（NME））；其中15份新药申请（10种新分子实体）进行了成像研究。主要的成像方式是正电子发射断层扫描。成像主要针对用于治疗精神分裂症、抑郁症、多发性硬化症和偏头痛的药物。大多数研究评估了受体占有率或概念验证。文中讨论了与药物或药物类别的剂量、疗效、安全性或进一步研发相关的实例（包括文献）。成像有助于中枢神经系统（CNS）活性药物的最佳临床研发。其更广泛应用的机会是存在的，这有助于增进对CNS活性药物临床药理学的理解。
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