Abstract：
Depressive disorders are one of the most common mental disorders globally and progress in treating these disorders has been hampered, in part, by a lack of suitable nonclinical efficacy tests. Two common tests used in nonclinical efficacy studies of antidepressants-the forced swim test (FST) and tail suspension test (TST)-have come under criticism in recent years for their inconsistency and lack of validity, yet they continue to be used in the pharmaceutical industry. In this review, we provide a rationale for why international pharmaceutical regulatory and guidance agencies should begin issuing direction on methods for non-clinical efficacy testing that traditionally use the FST and TST, particularly considering that some regulators, such as those in the U.S. and E.U., allow the authorization of clinical trials to proceed without requiring tests in animals. The area of antidepressant drug discovery represents an important opportunity for reducing the attrition of psychiatric drugs, harmonizing regulatory requirements, and reducing animal use. Specific recommendations for the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) have been provided.
摘要：
抑郁症是全球最常见的精神障碍之一，治疗这些疾病的进展受到阻碍。在某种程度上,缺乏合适的非临床疗效测试。抗抑郁药非临床疗效研究中使用的两种常见测试-强迫游泳测试（FST）和尾部悬吊测试（TST）-近年来因其不一致和缺乏有效性而受到批评。但它们仍在制药行业中使用。在这次审查中,我们提供了一个理由，说明为什么国际药品监管和指导机构应该开始发布关于传统上使用FST和TST的非临床疗效测试方法的指导，特别是考虑到一些监管机构，比如美国和欧盟，允许在不需要动物试验的情况下进行临床试验的授权。抗抑郁药物发现领域代表了减少精神科药物消耗的重要机会，协调监管要求，减少动物的使用。已为国际人用药品技术要求协调理事会（ICH）提供了具体建议。
