Module 9 Therapeutic Index
Medications are quite _____ between patients - answer variable
the response to medication is influenced by (3) - answer genetics, disease state, and
the environment.
Phase 1 evaluating? - answer-20-100 health volunteers
-evalutation of pharmacodynamics and pharmacokinetics
-Animal studies guide dosing
Phase 2 what is dtermined - answer-In 300-500 patients with the disorder
-Short term trial to determine efficacy and side effects
-Dose-response is determined
Phase 2 clinical trials establish dose response information over a range of doses
Phase 3 what is verified? - answer-500-5000 patients with target disorder
-efficacy verified and long term side effects evaluated.
Phase 4 - answer-post marketing surveillance
Why do we set an endpoint? Example - answerTo determine interpatient variability in
response to medications, we first set an endpoint. For example, if we were talking about
an analgesic drug, the endpoint would be pain relief.
What data is plotted on a frequency distribution curve? - answerFrom phase 2 clinical
trial data we can evaluate the number of patients that experience pain relief from each
dose of the drug.
What is the ED50 - answerThe average effective dose (ED50) is at the peak of the
frequency distribution curve.
The ED50 is the dose required to produce a thereapuetic response in 50% of the
population.
The ED50 is often used as the initial dose for therapy
Dosing Implications - answerIf all patients are given the ED50 as a starting dose, some
patients will have more drug than they need and others will not have enough as seen in
the graph
below.
The initial dose of a drug is a starting point, however many patients will require dose
adjustments to optimize efficacy and minimize adverse events.
Medications are quite _____ between patients - answer variable
the response to medication is influenced by (3) - answer genetics, disease state, and
the environment.
Phase 1 evaluating? - answer-20-100 health volunteers
-evalutation of pharmacodynamics and pharmacokinetics
-Animal studies guide dosing
Phase 2 what is dtermined - answer-In 300-500 patients with the disorder
-Short term trial to determine efficacy and side effects
-Dose-response is determined
Phase 2 clinical trials establish dose response information over a range of doses
Phase 3 what is verified? - answer-500-5000 patients with target disorder
-efficacy verified and long term side effects evaluated.
Phase 4 - answer-post marketing surveillance
Why do we set an endpoint? Example - answerTo determine interpatient variability in
response to medications, we first set an endpoint. For example, if we were talking about
an analgesic drug, the endpoint would be pain relief.
What data is plotted on a frequency distribution curve? - answerFrom phase 2 clinical
trial data we can evaluate the number of patients that experience pain relief from each
dose of the drug.
What is the ED50 - answerThe average effective dose (ED50) is at the peak of the
frequency distribution curve.
The ED50 is the dose required to produce a thereapuetic response in 50% of the
population.
The ED50 is often used as the initial dose for therapy
Dosing Implications - answerIf all patients are given the ED50 as a starting dose, some
patients will have more drug than they need and others will not have enough as seen in
the graph
below.
The initial dose of a drug is a starting point, however many patients will require dose
adjustments to optimize efficacy and minimize adverse events.
