Parallel line bioassay in practice. Practical aspects of design, analysis, and regulatory requirements from the...

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.