Randomized clinical trial is the most effective way to determine whether a cause-and-effect relationship exists between an intervention and a predefined clinical outcome. Much attention has been paid to the internal validity of a clinical trial, ie the extent to which the design and conduct of a trial eliminates the possibility of bias. Undoubtedly, high internal validity is necessary to unequivocally link observed clinical responses to the tested intervention. Nevertheless, it does not address the generalizability (ie external validity) of the causal relationship to patients other than those in the original study population. Even if internal validity is ensured, insufficient external validity may reduce the applicability of randomized clinical trial findings. In this context, quantitative modeling may play an important role for understanding the clinical consequences of drug use in patient populations who were underrepresented during clinical development. In this webinar we will go over two case studies leveraging IVIVE-PBPK modeling to prospect the impact of HIV and cystic fibrosis on the oral absorption of two broadly prescribed BCS 2 drugs.
Presenter:
Dr. Rodrigo Cristofoletti, assistant professor, Center for Pharmacometrics and Systems Pharmacology , Department of Pharmaceutics, University of Florida