Understanding the dose selection process is key in drug development.
TORONTO (PRWEB) May 15, 2020
How can companies reach their early clinical milestones in 2020? Can they look for ways to accelerate drug development programs under such tight timelines? PRA Health Sciences works across the US and Europe to provide effective tools to help meet these timelines.
To advance a drug into first-in-human (FIH) clinical trials, companies must invest carefully in drug substance, which can be in scarce supply. It is important to integrate formulation development and adaptive GMP manufacturing with clinical research.
In this webinar, viewers will learn how having the right flexibility with drug formulation can help accelerate the program. PRA has been manufacturing investigational medicinal products (IMPs) in early clinical trials for more than 15 years as this trend has evolved.
Understanding the dose selection process is key in drug development. The dose escalation scheme in first-in-human studies is often of traditional design, with fixed cohort sizes throughout the escalation scheme. PRA is currently exploring a pharmacology-guided rule-based adaptive dose escalation design that aims at making ‘best use’ of healthy subjects participating in early clinical programs.
Join Arjen Akkerman, Senior Manager, CMC QP, PRA Health Sciences and Ewoud-Jan van Hoogdalem, PharmD, PhD, Vice President, Scientific Affairs – Clinical Pharmacology, PRA Health Sciences in a live webinar on Tuesday, June 2, 2020 at 11:30am EDT (4:30pm BST/UK).
For more information or to register for this event, visit Efficient Dose Escalation in First-in-Human Studies.
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