14. toxicology - basics and risk assessment

what is toxicology

study of adverse effects of chemicals, drugs on living organisms

what is the importance of toxicology

• for pharmaceuticals; toxicology helps provide appropriate information for a compound to proceed safely through clinical trials to registration

• examines the mechanism of toxic findings & identifies the unacceptable

• support “safe clinical doses

• evaluate potential of compound to cause harm on acute & chronic administration or in high risk populations (i.e. aged, children, pregnancy)

what is the role of a toxicologist

• Distinguish “normal” pharmacology from “abnormal”
  pharmacology (toxicity)
  • Examine a molecule’s intrinsic toxic potential (toxicity)
  • Identify potential adverse effects (hazard identification)
  • Clarify relationship between magnitude of exposure
  and occurrence of adverse effect (dose-response
  assessment)
  • Extrapolate to human situation (population, route and
  magnitude) (exposure assessment)
  • Determine likelihood of human experiencing adverse
  effect (risk characterisation)

what is the risk assessment process

cannot predict an absolute “zero risk” (despite demands of general public