ADME 101: Lessons on Running a Successful Clinical Mass Balance Trial

Life Sciences, Pharmaceutical Regulation, Pharmaceutical, Drug Safety, Preclinical,
  • Tuesday, April 07, 2020

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.

Speakers

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Jennifer Foster, Pharm D, RP, Authorized Nuclear Pharmacist, Clinical Research Pharmacist in Charge, Celerion

Dr. Foster is the pharmacist in charge at Celerion’s Lincoln, Nebraska site. She is responsible for overseeing all ADME studies from a pharmacy, licensing, and total radioactivity reporting perspective. She has worked on nearly 100 ADME studies with all varieties of formulations and challenges. Dr. Foster graduated from the University of Nebraska Medical Center in 2001 with a Pharm D. In 2016, she completed the Authorized Nuclear Pharmacist program from Purdue University. She joined MDS Pharma Services in August of 2001 in the pharmacy as a Clinical Research Pharmacist. She transitioned to Celerion in 2010.

Message Presenter

Brandon Lester, Associate Director, Clinical Operations, Celerion

Mr. Lester is responsible for overseeing the Celerion staff that manages the execution, compliance, and quality of clinical trials run at Celerion’s Lincoln, Nebraska site. In addition, for ADME clinical trials, he is responsible for the laboratory where samples are analyzed in real time to determine radioactivity concentrations and determination of participant release criteria. Mr. Lester graduated from the University of Nebraska Lincoln with a bachelor’s degree in biological sciences. He joined MDS Pharma Services in 2006 as a clinical conduct technician/phlebotomist and transitioned to Celerion in 2010.  Previous positions include Clinical Study Manager, Clinical Conduct Supervisor and Bioanalytical Analyst.

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Who Should Attend?

This webinar will provide valuable assistance to all FDA and EMEA regulated companies that need to execute an ADME study, including companies in the pharmaceutical and biotech fields. Personnel who will find this webinar especially beneficial include:

  • QA and QC Managers
  • Operations Managers
  • Regulatory Compliance Managers
  • CMC Managers
  • Consultants

What You Will Learn

  • The critical steps needed to start an ADME study will be reviewed
  • Human Dosimetry Report – what it is and where to get the information and what to do if the report still needs to be written
  • Radiolabeled Investigational Product – how to handle the challenge
  • Regulatory requirements in Nebraska for Celerion’s radioactive materials license
  • Confirming the accurate radioactive dose
  • Ensuring all samples are collected for analysis
  • How to collect data and what should be collected

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Celerion

Celerion, a global leader in early clinical research services offers a unique combination of medical expertise, clinical operations experience and scientific excellence that gives our clients the confidence to make fast, accurate decisions about their drug development path. For fifty years, Celerion has leveraged the latest operational concepts and technologies to execute safety/tolerability, pharmacokinetic and pharmacodynamics studies in highly controlled clinic environments. These include first-in-human dose escalation, drug-drug interaction, cardiac safety, bioequivalence and bioavailability, metabolism and excretion studies as well as pharmacokinetic evaluations in patients with impaired renal or hepatic function. Celerion offers feasibility, data management, biostatistics, clinical monitoring, and bioanalytical services. Our founding mission is to help our clients get their drugs to market quickly, so that they touch the lives of our family, friends and people in need around the world. For more information, please visit www.celerion.com.

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