Drug toxicology

Question 1

what is the drug safety cycle comprised of

Answer 1

->risk assessment->risk management->hazard monitoring->hazard identification->

Question 2

Probability of toxicity equation

Answer 2

Probability of toxicity equation=total exposure x likelihood

Question 3

Why do safety evaluation occur in all stages

Answer 3

1. To design, select&develop best compounds as new drugs
2. to understand the exposure-response relationship for effects that may be predictive of adverse events
3. to protect clinical trial patients from adverse events
4. to understand mechanism of adverse events in clinical trials and throughout the lifecycle of drug

Question 4

Where is safety incorporated into drug discovery and development

Answer 4

early stage safety evaluation, late discovery stage safety evaluation, phase I safety and tolerability, Phase II efficacy in selected patient population

Question 5

Probability in safety evaluation

Answer 5

Efficacy: On target pharmacology, high likelihood of effect
safety pharmacology: on target and off target pharmacology has high likelihood of effect but require greater exposure (small group sizes)
toxicology: lower likelihood events may require both high exposure and larger group sizes
Pharmacovigilance: adverse drug reactions may only be detectable by post-marketing surveillance