Regulatory guidelines validation protocols

Many and varied field techniques involved in the planning, execution, and direction of the field portion of worker exposure and re-entry studies have been considered. Suffice it to say that there are many ways to perform such studies, and the important thing to remember is that good scientific thought and planning will produce an excellent study. The scientific validity of such studies should rest on the basic principles of science. There are various guidelines and protocols which may be followed for regulatory... 

NIR methods can be validated by the conventional protocols described in ICH and other regulatory guidelines as they are currently written however, some modifications have to be made to account for differences between spectrophotometric and chromatographic experimental parameters. For example, spiked recovery experiments are not relevant because NIR responses are sensitive to the production process. The criteria suggested for validating a NIR transmission method include ... 

For most regulatory applications, the method chosen will have been subjected to preliminary method development studies and a collaborative study, both carried out according to standard protocols. This process, and subsequent acceptance, forms the validation of the method. For example, the AOAC/IUPAC protocol [5, 6] provides guidelines for both method development and collaborative study. Typically, method development forms an iterative process of performance evaluation and refinement, using increasingly powerful tests as development progresses, and culminating in collaborative study. On the basis of the results of these studies,... 

Regulatory Acceptance. The comet assay is widely accepted by regulatory agencies, even though it was only relatively recently developed and is still being validated. No OECD guidelines are yet available, but several publications provide internationally agreed protocol recommendations (Tice et al. 2000 Hartmann et al. 2003 Burhnson et al. 2007). 

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