Drug efficacy and safety are key factors in ensuring effective First Time in Human (FTiH) trials. Analysis of dosing decisions is vital, providing clarity on the factors influencing the decided approach.
FTiH challenges include:
- Project teams and individuals presenting in their own “styles” leading to a lack of consistency
- No common data repository wasting time and effort sending data to build more complete pictures
- Representations of predicted human exposure on the same graph as pre-clinical exposure due to lack of correlation points.
- Receptor occupancy and bio-marker data produced to scale on the same graph as AUC or Cmax exposure.
iNCAS is an application that helps combat these challenges and enables faster, more
intuitive decisions. This multi-user application improves the FTiH safety decision making
iNCAS allows users to view and interact with graphical displays, to perform predictive
modelling and facilitate sound decision making regarding ongoing safety and dosage
regimes. The application has the capabilities to present against many criteria (AUC, CMax, receptors, bio-markers). iNCAS has been specifically designed to:
- Present study data as an interactive graph
- Show doses and corresponding exposures
- Identify toxicology findings from individual doses, distinguishing adverse and non-adverse findings
- Centralise and version key information on which dosing decisions are to be made
- Observe exposure range for each study
- Derive and display the NOAEL point
- Indicate the species most sensitive to the compound
- Combine human and pre-clinical safety data together on a single graph
- Provide a means of comparing the safety and efficacies of different compounds
- Aid identification of different species through consistent colour coding
“Safety is paramount in clinical drug development. However, predicting drug safety is not only a matter of novel techniques, it is also a matter of insight. An accurate evaluation of drug safety depends upon the availability of tools like iNCAS which enables the review of findings across non-clinical species and the integration of such results with pharmacokinetic and pharmacodynamic data in humans. Furthermore, as novel compounds are developed, it is essential to identify the potential for class effects as early as possible. iNCAS brings the safety review process to the 21st Century.”
Oscar della Pasqua, Director, CPMS, GlaxoSmithKline
Mango Solutions are pleased to offer web demonstrations of iNCAS upon request