Emerging guidelines from the US Food and Drug Administration (FDA) and US Pharmacopeia (USP) require that investigational products administered for Phase I clinical research be produced to the highest quality standard possible for safe use in humans. As such, compliant compounding suites and on-site pharmacy activities for compounded drugs can be instrumental to the success of a drug development program.
In this webinar, the featured speaker Dr. Jennifer Foster will discuss Phase I pharmacy compounding with an emphasis on ADME (Absorption, Distribution, Metabolism and Excretion) studies. She will describe in detail the advantages of onsite pharmacy compounding as well as current USP regulations for compounded drugs. She will also share the challenges of extemporaneous compounding, formulation and meeting timelines.
Furthermore, Dr. Foster will cover new pharmacy regulations including the requirement of USP <795>, <797> and <800> in extemporaneous compounding. She will highlight Celerion’s extensive compounding experience based on many studies conducted in their Lincoln, Nebraska and Phoenix, Arizona facilities.
Speaker
Jennifer Foster, Pharm D, RP, Authorized Nuclear Pharmacist, Director of Global Pharmacy Operations, Celerion
Dr. Foster is the Director of Global Pharmacy Operations at Celerion and is located at the Lincoln, Nebraska site. She is responsible for overseeing all three Celerion pharmacies as well as ADME studies from a pharmacy, licensing and total radioactivity reporting perspective. She has worked on over 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 PresenterWho Should Attend?
- QA and QC Managers
- Operations Managers
- Regulatory Compliance Managers
- Chemistry, Manufacturing and Controls (CMC) Managers
- Consultants
What You Will Learn
- Updated USP <795>, <797> and <800> Regulations
- Benefits of onsite pharmacy compounding
- How to choose a clinical research organization (CRO) with an adequate compounding facility and properly trained staff
- Tips for making a Phase I study successful
Xtalks Partner
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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