Selected Auditing Services

Lucid routinely performs audits of toxicokinetic / pharmacokinetic (TK/PK) reports.

We perform the audits by examining the analytical report to determine the correct analytical results that should be included in the TK/PK report.  We then recalculate 100% of the summary results that are included in the report. 

We also visually verify that the graphs in the report were constructed accurately. 

We then recalculate all of the pharmacokinetic parameters to assure the values in the report are correct.  We also examine the final results that are reported in the text of the report to make sure the text accurately presents the data. 

Finally, we review the conclusions drawn from the data to make sure the conclusions are supported by the original analytical data and the calculated parameters and graphs.

●  The specific example in this summary was a recently prepared CTD for dapsone in a topical gel.  This CTD included information from 53 different studies. 

●  Each entry in the CTD was verified by going back to the original study report.

●  Due to the large size of the CTD, a traditional audit report was not feasible.  Instead, our auditors scanned every page of the CTD that contained an error, and using Adobe^® Acrobat^®, our auditors highlighted the original result and included the correct result in red.  Our auditors then scanned the original study page associated with the CTD error, thus providing an electronic copy of each finding and the source material.

●  By providing a visual indication of the error, the correct value and a copy of the correct result from the original study, our client was able to respond much more quickly to our findings and revise the CTD.