Module 5 Presentations

16/07/2024

Introduction Continued

BEWARE! • Toxicology is an interpretative science • This allows a plethora of opinions to be raised about the most mundane aspects of any study • Guidances and Standards are not the same • Guidances provide a “recipe” • Standards provide “instructions” • However, as we all know: • Both can be interpreted different, just watch Bake-off or assemble some Ikea furniture!

The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

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CLINICAL TRIALS

• Phase ‘Zero’ – Exploratory, Mechanistic, Investigative studies • Phase I studies – Human Pharmacology studies • single dose studies, dose escalation and short term repeated dose studies to evaluate pharmacokinetic parameters and tolerance • usually in healthy volunteers but may include ‘disease models’ or patients (oncology) • Phase II studies – Therapeutic Exploratory studies • exploratory efficacy and safety studies in patients • Phase III studies – Therapeutic Confirmatory studies • efficacy and safety in patient populations

The Organisation for Professionals in Regulatory Affairs

Module 5 Lecture 3 – Nonclinical safety assessment

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