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Safety Issues in First-in-Human Studies
Session Chair(s)
David Jones, MS
Consultant, Regulatory Pharmaco-Toxicologist
ApconiX, United Kingdom
The session deals with overcoming or assessing safety concerns and issues early in development and exploring some of the safety issues that you can address in early clinical trials with a focus on biomarkers. It showcases where preclinical and clinical meet demonstrating a variety of organ markers. Examples of different organ systems impacted or assessed may include use of markers in renal toxicity, testicular safety or cardiac assessments as examples.
Learning Objective : Identify methods that are useful to address early safety issues in FIH studies which is originally seen in toxicity data.
Speaker(s)
The New EU Guidance for First-In-Human Clinical Trials
David Jones, MS
ApconiX, United Kingdom
Consultant, Regulatory Pharmaco-Toxicologist
Safety Issues in First-in-Human Studies
Charu Gautam, MD
IQVIA, India
Senior Medical Director
First-In-Human Nonclinical Testing and Starting Dose Considerations
Paul Baldrick, PhD
Covance Inc., United Kingdom
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