A CHA Case Study
Multi-Company, Collaborative Project:
TK Optimization

Description
Exploring alternate approaches for evaluating exposure in rat safety studies that do not require the use of satellite TK groups by collecting TK reports from Members, and then calculating exposure based on the full data sets, and comparing this to exposure calculated on simulated sparse datasets (i.e. subsets of the original data).  Two algorithms for calculating exposure on sparse datasets were evaluated.

Companies/Project Duration: 8 companies/9 months
Outcome & Benefits

• The general method of Holder, et al. as implemented in the Kinetica software package proved robust for calculating exposure when comparing reduced data sets to the complete data sets
• Utilizing data from multiple companies provided a truly diverse and rich source of data for assessment (over 100 PK curves were evaluated, and many were “not well behaved”).
• Reduced costs when compared to one company validating this approach individually
• Population PK approaches did not prove satisfactory for this estimation of exposure

Deliverables
Final report (50+ pages) detailing the comparison of methods and their respective results.
Summary of survey on how member companies are conducting their evaluations.
Data sets that can be utilized by members to test their own approaches.

Feasibility Assessment Project - For more information please call Eric Glazer at 781-547-0203 or contact him by email.