The AAPS Conference: PharmSci360 Held November 4th – November 7th Highlights the importance of Modeling and Simulation in Clinical Drug Development. KinderPharm’s Pharmacokinetic Scientist were there to share our expertise in PBPK Modeling and Population PK approaches.
PBPK Modeling and Clinical Pharmacology in Regulatory Applications & Decision Making
The ability to accurately predict drug absorption and disposition during drug product development is increasingly relevant today. Modeling and simulation tools and clinical pharmacology techniques provide a quantitative mechanistic framework for predicting and assessing systemic and tissue concentration-time profiles, and can thus provide a valuable resource to support decisions at various stages (early development, late development, post-approval, and lifecycle management) of the drug development process, regulatory interactions, and personalized treatment of patients. A significant step forward for this field is the inclusion of PBPK modeling in submissions to regulatory agencies and acceptance of such models by the agencies to waive and/or supplement clinical studies, and to support labeling.
Pharmacogenetics, Big Data, and Population Pharmacokinetics in Personalized Medicine and Special Population
One of the primary aims of personalized medicine is individualization of the therapy. Advances in molecular genetics and biomarkers, and the ability to quantify that into a therapeutic regimen, which is tailored to the individual patient, has gained significant attention. Also, the ability to model large datasets and population PK approaches enable a quantitative approach to dose selection and dosing regimen based on individual physiology and pathophysiology. However, individualization of drug therapy also raises numerous challenges such as the development of appropriate diagnostic tools for biomarkers; identification of correct disease targets; cost-effective devices; and developing accurate PK/PD models, among others. The personalized medicine’s advances, challenges, and regulatory perspectives are being discussed.
To receive more information on the use of PBPK Modeling, Population PK Modeling and/or PK/PD models in the various stages of drug development, contact Alberto Bryan at ABryan@kinderpharm.com or call 610-458-1051.