Translational modeling in support of nonclinical safety assessments

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 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