The FDA recently approved updated regulatory guidance for drug-drug interactions (DDIs). This webinar will focus on how to follow the FDA guidance, design in vitro studies, interpret the data and assess potential drug-drug interactions, using both static and Physiologically Based Pharmacokinetic (PBPK) models.
We will also share our interpretations, as regulatory agencies recommend different approaches for calculation of the DDI potentials including static and PBPK models.
Co-administration of multiple drugs may potentially cause a drug-drug interaction (DDI) in which one drug alters the exposure of another, resulting in either therapeutic failure or risk of a patient’s life. In vitro studies are key to assessing potential DDIs because they are cost-effective, time-saving and can help to understand the mechanisms of DDI and provide directives to clinical trials (clinical trials should not be used to screen potential DDIs because of high costs, lengthy duration and ethical considerations, but they should be used to confirm potential DDIs recommended from in vitro studies and corresponding modeling).
Join this informative webinar on static & PBPK modelling to assess potential DDIs.
Speaker
Daniel Albaugh, Sr. Manager, Global Metabolism and Environmental Sciences, Covance
- More than 20 years of drug development experience in the pharmaceutical industry
- Currently serves as Global Analytical Lead for Metabolism and Environmental Sciences
- Prior to his current position, served as Senior Manager, In Vitro Metabolism and Metabolite Identification, for Covance, where he managed a multi-disciplinary scientific team responsible for the conduct of In Vitro and In Vivo Metabolism and Metabolite Identification studies
- Previously served as Manager, Metabolism Laboratory Operations, for Covance, where he managed a multi-disciplinary team responsible for the conduct of In Vitro Metabolism studies
- Before joining Covance, held number of positions with Boehringer Ingelheim Pharmaceuticals in Ridgefield, Connecticut, where most recently he was assigned as a DMPK Project Discipline Leader
Who Should Attend?
This webinar will appeal to individuals with the following or related job titles:
- Safety pharmacology professionals
- Heads of preclinical R&D
- Lead scientists
What You Will Learn
In this webinar, attendees will learn about:
- Assessment of potential DDIs by in vitro studies
- Application of the FDA guidance to DDI study design, data interpretation and modelling
- Understanding of fundamental theories and development strategies of PBPK models
- Benefits and applications of PBPK models to preclinical drug development and design of first clinical trials
Xtalks Partner
Covance Inc.
Covance is a business segment of LabCorp, a leading global life sciences company, which provides contract research services to the drug, medical device and diagnostics, crop protection and chemical industries. Employing over 21,000 people worldwide, we are the world’s most comprehensive CRO, dedicated to improving health and improving lives.
Covance is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical, and regulatory expertise. We generate more safety and efficacy data to support drug approvals than any other company, supporting our clients’ complete lifecycle management.
Together with our clients, Covance transforms today’s healthcare challenges into tomorrow’s solutions. Visit us at www.covance.com.
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