There will be a special focus on the challenges of extemporaneous compounding, sample analysis, and meeting timelines.
TORONTO (PRWEB) March 19, 2020
Join Jennifer Foster, Pharm D, RP, Authorized Nuclear Pharmacist, Clinical Research Pharmacist in Charge, Celerion and Brandon Lester, Associate Director, Clinical Operations, Celerion in a live webinar on Tuesday, April 07, 2020 at 11am EDT/NA (4pm BST/UK).
In this one-hour webinar, featured speakers will focus on ADME (Absorption, Distribution, Metabolism, and Excretion) studies, from planning to design and sample collection to completion. ADME studies provide important information regarding absorption, distribution, metabolism and excretion of compounds into urine and feces. The information generated from these studies is useful in determining whether the kidney or liver is an important organ in elimination, and whether there is any safety concern in hepatic or renally impaired populations. While these studies are typically not included as part of an IND, they are conducted later in development and are required for NDA filing.
Join this webinar to hear a detailed discussion as to when you will be required to conduct an ADME study and what is required for the study. This webinar will include an evaluation of the most efficient study design for your situation. With an easy to follow checklist, our speakers will walk through the process of conducting an ADME study. There will be a special focus on the challenges of extemporaneous compounding, sample analysis, and meeting timelines. New pharmacy regulations will be discussed including the requirement of USP 795, 797, and 800 in extemporaneous compounding. The challenges of sample collection, real-time data reporting and quick reporting will be highlighted. Troubleshooting parameters, including ways to ensure the accurate dose is given and suggestions for total sample recovery will be discussed.
Celerion’s extensive experience is based on a considerable number of studies conducted in their Lincoln, Nebraska facility. Their clinic, liquid scintillation-counting lab, and new compounding pharmacy are all located in the same building, allowing real-time sample analysis and participant recovery results every day.
For more information or to register for this event, visit ADME 101: Lessons on Running a Successful Clinical Mass Balance Trial.
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