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Lecture 11

Lecture 11+ last class.docx

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Brock University
Caroline Starrs

Lecture 11 Pharmaceuticals/food additives - Must be tested and evaluated toxicologically in all aspects - Cumulative 2+2= 4 - Autogenetic 2+ 2 = 3 (reduces efficacy) - Synergistic 2+2 = 7 (makes stronger) - Only chemicals judged safe are accepted Clinical trials - Why are clinical trials needed? - Variations among people - Variation in course of diseases - Very few “breakthrough” treatments for chronic diseases - Makes inferences to population who require treatment in the future Pharmaceuticals Clinical trial - A prospective study comparing the effect and value of interventions against a control in human subjects - Typical time from synthesis to battle o 12 years Phase 1 testing (most clinical trials pay subjects, depending on the treatment) - 50-80 subjects - Complete guinea pigs - Safety - MTDO maximum tolerable dose - Pharmacokinetics (how its broken down) - Healthy subjects or may include subjects with known conditions - Interaction studies food, other meds o 1 year o 5 compounds enter trial Pharmacokinetics -study of absorption, distribution, metabolism, and elimination of drugs (ADME) Absorption Is it, or not? Where? Distribution Where? Correct place? Is it, or not? Metabolism What’s it broken down into? Elimination How? Phase 2 testing - 100-300 subjects who have target illness - Short term effectiveness - ED50effective dose for 50%) - 2 years - 5 compounds enter trial - Trials use subjects to specifically target disease Phase 3 testing 1000-3000 subjects -occasionally mult-centered -long-term 3 years 3-5 compounds enter trial Phase 4 testing - Long term surveillance - Health Canada/FDA - Up to 2.5 years - 1 compound approved Phase 5 testing -further trials and monitoring Phase 4/5 - Physicians may be asked/paid by drug company for access to effects and acceptance of drug by patient Drug names -Chemical Pharmaceuticals Effective dose ED 50 (MTO)- Toxic dose TD50 -therapeutic index (in between D an50TD 50 -T1 = TI = TD50ED 50 Therapeutic window - Control group study o Treatment absent o No active ingredient Placebo effect Prozac testing - Numbness 50% - Headache 25% - Fatigue 18% - Sensation of heaviness 18% - Unable to concentrate 15% - Drowsiness 10% - Nausea 10% Single Blind study - Patient does not know if the control group or treatment group Double blind study - Neither patient nor-researcher knows who is in the control group or treatment group -stops bias and “fixing” of data Advantages - Can see different reactions/side effects Disadvantages - Wash out period could
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