Understanding the Value of Continuity. Early phase development is a continuous journey from First-in-Human (FIH) to Proof-of-Concept (PoC). Yet frequent team and leadership transitions can create risk, slow decisions and dilute critical knowledge just as programs grow...
Conducting a definitive QT evaluation is a critical regulatory requirement for small molecule drug development. With evolving ICH guidance and increased interest in early phase QT strategies, biopharma companies face complex scientific and operational decisions that...
Clinical and behavioral studies are cornerstones of any Premarket Tobacco Product Application (PMTA) submission, from pharmacokinetic to actual use investigations. This webinar will explore the scientific and operational fundamentals of tobacco harm reduction (THR),...
From sterile compounding to handling controlled substances, a crucial aspect of conducting successful early phase trials is the careful preparation of both investigational and non-investigational products to be used in a clinical trial setting. With several different...
Human pain models have been established as effective, cost-efficient tools for evaluating the efficacy of analgesic drugs. Three acute pain models have been most commonly used in recent years: bunionectomy, third molar extraction and abdominoplasty. Each of these...
As most medications are primarily excreted through the kidneys or liver, most drugs in development will require a renal and/or hepatic insufficiency trial to assess the impact of organ impairment on the pharmacokinetic (PK) parameters of the investigational product....
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