Transformation of Toxicology data into Specific PDE’s
23rd April 2020 | 10:00am PDT, 1:00pm EST | Kim Li, PhD, DABT, MPH, Amgen Inc and Dries Cardoen, Team Leader of Study Directors at Nelson Laboratories, LLC |BOOK FREE SEAT FOR THIS WEBINAR
Permitted Daily Exposure (PDE) has origin in ICH Q3C: Impurities – Guideline for Residual Solvents. This webinar will discuss the principles and methods of applying PDEs to extractactables and leachables (E&L) impurities in pharmaceutical products. We will review the regulatory advice on the DO’s and DON’Ts. Then we will review the current toxicology risk assessment practice on data gathering, literature synthesis and selection of the critical studies with robust toxicity endpoints. We will show how the toxicity endpoints are transformed into chemical-specific PDE values with modifying factors. We will highlight the importance of clinical relevance to further refine the PDE values. For a case study, we will share an extraction study of a polyolefin bag for use with a lyophilized product. We will examine the risk matrix per USP <1664> Assessment of drug product leachables associated with pharmaceutical packaging/delivery systems. The toxicology assessment of the extractables profile of the bag will illustrate the derivation of chemical-specific PDEs, as well as the refinement by taking clinical relevance into consideration.
Presented by Kim Li, PhD, DABT, MPH, Amgen Inc.
Dr. Li is a board certified toxicologist with broad experience in R&D and Operations. She joined Amgen in 2004 and is currently the lead toxicologist on the extractables and leachables programs on container closure systems, drug delivery devices and single-use bioprocess systems. Kim is the chair of the Extractables and Leachables Safety Information Exchange (ELSIE) consortium. As a member of the Association for the Advancement of Medical Instrumentation (AAMI) Biological Evaluation Committee, Kim serves as the US expert to ISO/TC 194.
and Dries Cardoen, Team Leader of Study Directors – Inhalation/topical/transdermal products at Nelson Laboratories, LLC
Dries Cardoen received his Ph.D. from the Faculty of Biology at the University of Leuven (Belgium) in 2011. After his academic career as a post-doctoral researcher, he started at Nelson Labs (formerly Toxikon Europe) in 2013 as study director in the Extractables & Leachables Department. From the start, he specialized in E&L projects of inhalation drug products. He is currently leading the team of study directors that is specialized in E&L testing of inhalation drug products and topical and transdermal drug products.
Sponsored by Nelson Labs Europe
Nelson Labs, A Sotera Health company, is the leading, global provider of lab testing and expert consulting services. We perform microbiological and analytical laboratory tests across the medical device, pharmaceutical, and tissue industries. The company is regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex problems. We have over 700 scientists, technicians, and service specialists who diligently perform more than 700 rigorous tests in 13 global laboratory locations.
Based in Belgium, Nelson Labs Europe specializes in providing premium Extractables & Leachables testing services to the pharmaceutical and medical device industries. We also support pharmaceutical companies across the globe in developing worldwide compliance testing strategies to qualify container/closure applications and pharmaceutical production equipment from an Extractables & Leachables perspective.