Translational modeling in support of nonclinical safety assessments Thierry Lave, Head DMPK and TOX Project Leader and Modeling and Simulation, F. Hoffmann-La Roche Wednesday, March 19, 2014 12:00 - 1:00 pm EST
During this webinar, we will cover state-of-the-art, model-based approaches in support of nonclinical safety assessments. The discussion will be based on case studies and best practices, and we will provide a new perspective on the use of model-based approaches. Some answers to the following questions will be proposed during this webinar: What is a safe, efficacious dose regimen for humans? Which dosing regimen should be used for toxicology studies? Can we improve our profile by changing the formulation? What is the expected safety window in man? How can we handle sparse data from our preclinical tox studies? How can we improve study designs and analyses for more quantitative safety assessments of various types of organ toxicities (cardiovascular, hematological, CNS, etc...)? How far can we go in translating preclinical safety liabilities to man? This presentation will include some critical consideration of the value of model-based approaches for supporting safety assessments during drug discovery and development and what can be done to translate this to the clinical situation in man. Dr. Lave's presentation is a part of the monthly world-wide webinar series "Impact of Modeling & Simulation in Drug Development" hosted by Rosa & Co. LLC. The purpose of the "Impact" series is to foster the use of M&S activities in all phases of drug development by illustrating the advantages and enhancing the applicability of M&S in product discovery, development, and marketing programs. The series is intended for drug development project team members from discovery to phase IV clinical trials. This includes pharmacologists, ADME scientists, PK/PD modelers, clinical pharmacologists, clinical development team members, regulatory affairs specialists, and other interested professionals. Register for this free webinar at www.rosaandco.com/webinar.html<http://www.rosaandco.com/webinar.html>. After registering you will receive a confirmation email containing information about joining the webinar. More information about the webinar series, an archive of past webinars, and a list of future webinar speakers may be found at www.rosaandco.com/webinar.html<http://www.rosaandco.com/webinar.html>. Toufigh Gordi Toufigh Gordi, PhD President, PK/PD and Clinical Pharmacology Services Direct: 408-480-7314 Corp: 408-370-9800 Fax: 408-370-9810 [email protected]<mailto:[email protected]>
