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Using PBPK modeling to assess the impact of diseases on oral drug absorption: a tale of 2 drugs
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

Jun 29, 2022 08:00 AM in Pacific Time (US and Canada)

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Speakers

Rodrigo Cristofoletti
Assistant Professor, Center for Pharmacometrics & Systems Pharmacology, Department of Pharmaceutics @University of Florida
Rodrigo Cristofoletti, Ph.D., joined the University of Florida in 2019 as research assistant professor in the Center for Pharmacometrics and Systems Pharmacology (Orlando) in the Department of Pharmaceutics. He received his B.S. in Pharmaceutical Sciences from the University of Sao Paulo, Brazil in 2004. Dr. Cristofoletti received his Ph.D. summa cum laude from the Johann Wolfgang Goethe University (Frankfurt am Main, Germany) under the supervision of Dr. Jennifer Dressman in 2017. The Clinical Pharmacology & Biopharmaceutics Office of the Brazilian Drug Regulatory Agency (ANVISA) has been Dr. Cristofoletti’s place of employment for the last 15 years. While there, his research on oral drug absorption has helped in building scientific foundations for generic policies within Brazilian jurisdiction.