This short course introduces key considerations and data requirements for PBPK and PK/PD modeling of challenging drug modalities, emphasizing how computational approaches support decision making in drug discovery and development.

This short course delves into the emerging issue of "missed metabolites" in drug development, highlighting challenges, case studies, and advanced techniques to enhance metabolite detection and characterization.

This short course covers the design, purpose, and regulatory expectations of human radiolabeled mass balance studies, emphasizing their role in understanding drug disposition, informing drug development decisions, and supporting DDI assessments and PBPK modeling.

This short course explores the use of clinical probes and biomarkers to evaluate transporter-mediated drug-drug interactions, highlighting their role in drug development, study design, data interpretation, and regulatory guidance.

This course was developed by the ISSX Modeling and Simulation Focus Group and will be moderated by Maria Posada, Ph.D., Eli Lilly and Company, USA, Oliver Hatley, Ph.D., Certara UK, United Kingdom, and Jaydeep Yadav, Ph.D. Merck, USA. This short course will focus on the fundamentals of modeling and simulation, spanning several modeling disciplines, including PBPK, QSP, PopPK and Biopharmaceutics, (small molecules, peptides, proteins, or new modalities). The course will include the fundamentals for beginners, advancement, and application, as well as case examples.

This short course, featured during the 25th North American ISSX Meeting in September 2023, will focus on challenges and advances of transporter mediated drug disposition and translation from preclinical to human.

This short course, featured at the 25th North American ISSX Meeting in September 2023, is aimed at scientists desiring to gain experience in successful IND submissions that enable first-in-human (FIH) studies with clear line of sight to successful approvals.

This short course, featured during the 25th North American ISSX Meeting in September 2023, is designed to provide the audience with state-of-the-art perspectives on the pharmacokinetics (PK) of protein therapeutics.

This short course, featured during the 25th North American ISSX Meeting in September 2023, covers current best practices and regulatory guidance around in vitro studies assessing inhibition and induction of CYPs and UGTs, the use of the in vitro data to project DDIs using static and PBPK modeling, as well as the use of the data to design clinical DDI studies and inform product labels.

This short course, featured during the 24th North American ISSX Meeting in September 2021, reviews the fundamentals in the translation from preclinical data to FIH dose selection and data needed in support of successful IND application and clinical studies.