For example, many bioassays are based on animal challenge models, immunogenicity assessments, or other immunoassays that have unique features that should be considered when submitting analytical procedure and methods validation information.

• 比如说，许多生物分析是建立在动物挑战模式，免疫原性评估或其它有着独特特性的免疫分析基础上的，在递交分析方法和分析方法验证资料时需考虑这些独特的性质。