2015 SOT Eminent Toxicologist Lecture Series—Regulatory (Pharmaceutical) Toxicology

Lecturer: Ruth A. Roberts, PhD, ATS, ERT, FBTS, FRSB, FRCPath of the University of Birmingham.

Regulatory pharmaceutical toxicology provides a framework for testing and registration of new medicines to ensure patient and volunteer safety. In silico, in vitro, and in vivo toxicology studies are conducted sequentially, building a picture of the toxicity profile of each potential new drug. Although regulatory toxicology testing is specified by a set of international guidelines (defined by the International Council for Harmonization), each candidate drug requires a unique package of scientific tests that are designed, performed, and analyzed by skilled regulatory toxicologists. Most drugs that are not approved fail during this critical period due to safety and efficacy concerns. How well do animal tests predict clinical outcome? And how will we move towards replacing animals in drug safety testing? The framework for regulatory toxicology testing and the challenges are outlined with potential solutions.