Preclinical Safety

О курсе

Patient safety is of paramount importance for any drug discovery program.  This course looks at some of the lessons learned which have influenced how promising molecules are currently evaluated for safety risks.  In vitro and in vivo toxicology and safety studies are discussed, why they are performed, and how the data they provide guide a safety risk assessment, including determining a therapeutic index or safety window for a drug.  Finally, the course will look at how safety data guide human dose selection, and some of the studies performed during clinical development. Target audience: This course is suitable for life scientists, clinicians, and individuals from fields that support drug discovery (e.g., patents, finance, licensing, etc.) interested in learning more about the pharmaceutical/biotechnology sector. Advanced undergraduate coursework or practical familiarity/working knowledge in biological sciences and organic chemistry is recommended.

Навыки, которые вы освоите

Учитесь у экспертов

Erland Stevens, PhD

James G. Martin Professor of Chemistry, Davidson College

W. Ross Tracey, PhD

Associate Director, Biomedical Research Learning, Novartis

Douglas S. Auld, PhD

Associate Director, Discovery Sciences, Biomedical Research, Novartis

Alan P. Brown, PhD, DABT

Director, Preclinical Safety, Biomedical Research, Novartis

Sujal Deshmukh, PhD

Director, Pharmacokinetic Sciences, Biomedical Research, Novartis

Stephanie Dodd, MSc.

Associate Director, Chemical & Pharmaceutical Profiling, Development, Novartis

Sabine Guth, PhD

Director, Diseases Of Aging and Regenerative Medicine, Biomedical Research, Novartis

Thomas M. Smith, PhD

Associate Director, Early Strategic Partnerships Biomedical Research, Novartis