Norwood B J
Immunex Corporation, Bothell, WA 98021-5682, USA.
Dev Biol (Basel). 2002;107:57-62.
Bioassay technicians sometimes have limited statistical training and require more help when preparing bioassay data for filing with regulatory agencies. Three things should be considered when approaching problems in statistics: (i) Assess the situation: data should be checked for accuracy and bias; (ii) Is the situation resolving on its own? Are the skills in place to answer this question? (iii) If no to 2, find expert help. Some sources of variability in bioassays are listed. Some sources of expert help are listed. An example is given of how a statistics problem was solved by a technician unfamiliar with statistics. Some practical tips for design, analysis and regulatory issues are presented.
生物测定技术人员有时接受的统计培训有限，在为向监管机构提交而准备生物测定数据时需要更多帮助。处理统计问题时应考虑三件事：(i) 评估情况：应检查数据的准确性和偏差；(ii) 情况是否自行解决？是否具备回答这个问题的技能？(iii) 如果对问题2的回答是否定的，寻求专家帮助。列出了生物测定中一些变异性来源。列出了一些专家帮助来源。给出了一个不熟悉统计学的技术人员如何解决统计问题的示例。还介绍了设计、分析和监管问题的一些实用技巧。
