Author: Becca Bucci
Gene Therapy Immunogenicity 2022
AMCP Nexus 2022
3 Major Implications of New European Clinical Trial Regulations
Have you heard the buzz around the new European Union Clinical Trial Regulations (EU-CTR) for transparency and disclosure of clinical trial data? The goal of the EU-CTR is to create a more favorable environment for clinical research in Europe, as well as maintain the highest patient safety standards, and increased transparency of clinical trial information … Continued
Avoid the valley of death – increase confidence in translational research using biosimulation
The attrition rate of drug programs in early-stage development is high, with two-thirds of preclinical programs failing to move successfully to Phase 1. How do we better inform translational R&D decisions to de-risk investments and help increase probability of success? Physiologically-based pharmacokinetic (PBPK) modeling and simulation is a regulatory-adopted, versatile tool in drug development that … Continued
Sponsored Webcast: A Regulatory & Strategic Framework for Facilitating Pediatric Drug Development
Regulations in the US and Europe require and/or incentivize sponsors to evaluate their drugs (small molecules and biologics) for use in appropriate pediatric populations. It is generally agreed that that these regulations have stimulated new research efforts in pediatrics. It is essential that individuals, involved in global pharmaceutical research and development, are familiar with these … Continued
2022 ACoP13
2022 AAPS PharmSci 360
Why are Human Radiolabeled Mass-balance Studies Important in Clinical Pharmacology & Drug Development?
Human mass-balance studies are also called “C-14 studies” or “Absorption, Metabolism, and Excretion (AME) studies.”Drug developers conduct these studies of radiolabeled drugs to quantify the routes of elimination of the drug substance and characterize its metabolism. The FDA released its first guidance on human mass-balance studies recently. Both Sponsors and Regulators gain extensive insight … Continued
BioIT Europe 2022
Booth #36
