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Biomedical Basics

Toxicology in drug development

  • Created by Henry Stewart Talks
Published on October 29, 2026   5 min

A selection of talks on Pharmaceutical Sciences

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Welcome to this lecture on toxicology and drug development, providing an overview of early safety assessment methods in toxicology, including how chemical properties, metabolism, and exposure influence toxicity, and the key regulatory standards that guide testing. We will discuss the importance of the dose response relationship, approaches for establishing safe starting doses and the concept of safety margins. The presentation will also address mechanisms of organ specific toxicity using both in vitro and in vivo models, as well as current best practices and innovative alternatives in preclinical safety evaluation. Finally, we will highlight the integration of regulatory guidelines to ensure ethical and effective toxicological assessment throughout drug development. Toxicology is a critical component of drug development, ensuring new medicines are safe for human use. Early safety assessments identify and mitigate potential hazards posed by new compounds. Key principles involve understanding how chemical properties, metabolism, and exposure influence toxicity. Regulatory authorities like the FDA, EMA, and ICH set global safety standards. Risk assessment and safety margins help establish an acceptable benefit risk balance. Safety evaluation is continuous, guiding selection, dosing, and ongoing development. A foundational concept in toxicology is the dose response relationship. The dose makes the poison. The severity and incidence of

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