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Module 9 Notes.docx

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Department
Pharmacology
Course Code
Pharmacology 2060A/B
Professor
Angela Nissen

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Description
Module 9 - Interpatient variability in response to medications o Influenced by genetics, disease state and environment - Clinical trials...info in variability and response o Phase 1: pharmacokinetic studies ...how variable plasma concs o Phase 2: dose response relationship..300-500 patients..factors o Phase ¾: different characteristics, efficacy and long term side effects - Determine Interpatient variability/response o USE PHASE 2 o Establish dose response relationships..over range of doses o SET END POINT (ex. Pain relief) o PEAK OF frequency distribution curve = ED 50 (starting dose) - Implications o Doses need to be optimized o Wide therapeutic range...SAFE DRUG ...low risk of side effects OKAY TO USE ED50 o Narrow therapeutic range...no ED50 may experience toxicity  Therefore TITRATE !!! - Toxicity and Lethal Dose o Animal testing! ... use two different species (rodent and nonhuman primate (monkey)) o Average toxic dose (TD50) o Average lethal dose (LD50)...50% die  Expressed in mg/kg ... allows conversion to human weights - Therapeutic Index o Indicator of drugs safety o TI = TD50/ED50 o TI=LD50/ED50 o High therapeutic index = SAFE o SAFE = large space in between response dose, toxicity dose and lethal dose - Intersubject variability o Body weight/composition  Higher plasma conc in smaller person... WEIGHT  C
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