Global Approach in Safety Testing by Jan Willem Laan & Joseph J. DeGeorge

Author:Jan Willem Laan & Joseph J. DeGeorge
Language: eng
Format: epub
Publisher: Springer New York, New York, NY

7.12 Report Writing

This aspect was not included in the original guidance but addresses questions which are often raised when reporting toxicokinetic results. When reporting bioanalytical and toxicokinetic data, it is much easier, for both the author and the reviewer, to have each included as a separate contributor report usually as an appendix to the main toxicology report even though the data may be generated by different laboratories. The main toxicology report should have a short summary of the main toxicokinetic findings, referring back to the full toxicokinetic report in the appendix. The toxicokinetic report should reference full species matrix validation, how the analysis was performed, together with any statistical analysis employed (e.g. dose linearity) and provide any deviations from the protocol. The data including the individual concentration–time data and the toxicokinetic parameters from individual animals should be provided, together with descriptive statistics (e.g. mean ± SD, median and range), making full use of tables and figures. It is also useful for the reader to have a summary table of the exposure (C max and AUC0–24h) for the final dose, when steady state should have been reached, at the NOAEL. It should be remembered that a reader or reviewer of the report will want to find the data quickly and easily, so all the data should be rationally ordered and simply presented. The individual data are required to allow the reviewer to determine the variability, looking for outliers to see, for instance, if there is relationship to toxicological findings. The reviewer may even want to reanalyze the data, either using the methods employed in the report or using an alternative method for comparative purposes. Thus, all the data should be in an easily assessable form that will allow the reviewer to perform any additional evaluations (Table 7.3).Table 7.3Suggested contents, although not limited to, for inclusion in bioanalytical reports of toxicokinetic data and toxicokinetic reports

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