Design and Evaluation of Toxicokinetic Studies

Toxicokinetics is defined as the generation of pharmacokinetic data, either as an integral component in the conduct of nonclinical toxicity studies or in specially designed supportive studies, in order to assess systemic exposure. These data may be used in the interpretation of toxicology findings and their relevance to clinical safety issues (ICH Guidance Toxicokinetics 1994). 

In the ICH Guidance Toxicokinetics 1994 it states The number of animals to be used should be the minimum consistent with generating adequate tox- 

In Note 8 of the ICH Guidance Toxicokinetics 1994 it is stated It is often considered unnecessary to assay samples from control groups. Samples may be collected and then assayed if it is deemed that this may help in the interpretation of the toxicity findings, or in the valida- 

The analytical methods to be used in toxicokinetic studies should be specific for the entity to be measured and of an adequate accuracy and precision. The limit of quantification should be adequate for the measurement of the range of concentrations anticipated to occur in the generation of the toxicokinetic data (ICH Guidance Toxicokinetics 1994). 

The following aspects should be considered for toxicokinetic evaluation  

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