Chester A, Hallesy D, Andrew F
Neurobehav Toxicol Teratol. 1985 Nov-Dec;7(6):745-52.
A questionnaire was sent to 75 representatives of 71 pharmaceutical companies or toxicology contract laboratories to determine the extent of behavioral teratology (neurobehavioral development) testing currently conducted by the pharmaceutical industry. The form used was a modification of one used by Buelke-Sam and Kimmel. The present survey made inquiry about test methods employed, test species, animal age at testing. CNS functions believed to be measured, other toxicologic endpoints measured concomitantly, correlation of other observations with behavioral alterations, advantages and disadvantages of test methods used, influence of current regulatory requirements on the extent of testing, and utilization of positive controls. Forty-five responses (60%) were received and 26 of these (58%) indicated that some behavioral testing was being conducted. None of the respondents was performing the same combination of specific tests or classes of tests. As in 1978, testing facilities acknowledged a need for some kind of behavioral testing, but with flexibility as to specific methods. Of 13 specified classes of behavior, about half of the respondents were testing 6 classes or more of behavior and were evaluating all agents under development. The primary test subject was the weanling rat. Overall, there have been no major changes in the frequency of sampling from behavioral classes or use of specific tests of behavior since 1978.
一份调查问卷被发送给了71家制药公司或毒理学合同实验室的75名代表,以确定制药行业目前进行行为致畸学(神经行为发育)测试的程度。所使用的表格是对Buelke-Sam和Kimmel所使用表格的修改。本次调查询问了所采用的测试方法、测试物种、测试时的动物年龄、被认为可测量的中枢神经系统功能、同时测量的其他毒理学终点、其他观察结果与行为改变的相关性、所使用测试方法的优缺点、当前监管要求对测试程度的影响以及阳性对照的使用情况。共收到45份回复(60%),其中26份(58%)表明正在进行一些行为测试。没有一位受访者进行相同组合的特定测试或测试类别。与1978年一样,测试机构承认需要某种行为测试,但在具体方法上具有灵活性。在13种特定的行为类别中,约一半的受访者测试6种或更多类别的行为,并对所有正在研发的药物进行评估。主要测试对象是断奶大鼠。总体而言,自1978年以来,行为类别抽样频率或特定行为测试的使用情况没有重大变化。