CHM 4123 Lecture Notes - Lecture 9: Pharmacodynamics, Pharmacokinetics, Health Canada
11 Feb 2020
School
Department
Course
Professor
Document Summary
Interventional trial participants receive specific interventions (drugs, devices, procedures, changes to behaviour) according to the research plan or protocol. Clinical development; series of clinical trials that assess the effects of an investigational product in human subjects that generates data on its potential benefit to risk profile. First study carried out on humans (healthy volunteers) after the drug has met safety efficacy parameters in pre-clinical models. Evaluating the safety profile at potential therapeutic doses: pharmacokinetics, pharmacodynamics, tolerability (adverse events) Defines: a minimally active dose to the maximally tolerated dose range. Assessing efficacy and safety in patients who have the disease that the investigational drug is designed to treat. Phase iia: proof of concept (drug compared to placebo in a single dose study to assess acute affects in patients. Phase iib; dose ranging study (safety dosing, schedules and pharmacokinetics) Defines: if the drug is judged as likely to be ineffective or unsafe/intolerable and if the benefit to risk profile is favourable.
