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Pharmacology NURS 7550 Exam 1 Study Guide.docx

Pharmacology NURS 7550 Exam 1 Study Guide.docx -...

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Pharmacology NURS 7550 Exam 1 Study Guide [Pharmacology] a. “Pharmakon”: Poison/ poison + “ology” : study of b. Paracelsus: grandfather of pharmacology or father of toxicology said i. “the dose makes the poison” or “ a lot kills, a little cures” ii. If some is good a lot is better = NOT TRUE because we are dealing with poison 2. Forms of Pharmacology (specialties in pharmacology) a. Pharmacotherapeutics: study of the effects of drug therapeutic uses i. How we use meds in the clinical settings ii. How we prescribe b. Pharmacogenomics: branch of pharmacology that focuses on the effects of genetic make-up that will lead to variable drug responses i. Lab test: testing genetic make up to see if a certain drug will work better for this person c. Pharmacoeconomics: study of the cost of drug therapy and its economic impact i. NP needs to know ii. Choosing medication, what can the patient afford, if they can’t afford it they won’t take it 3. Drug Development (how researched and developed) a. 2014 Study showed, in the U.S. costs 2.6 billion for 1 new medication to go from the lab to the pharmacists shelf. and it takes about 8.5 years i. Think about all the drugs are being studied. b. Steps i. Stage 1 1. Preclinical Investigation (1~3 years): development of new molecular structures a. Exploration of therapeutic potentials: Putting together chemicals together to see if it produces harmful/beneficial effects b. Dosage formulation and stability of compounds c. Toxicology and safety testing of new compoun d. Non-human studies ii. Stage 2 ( Phase 1~3 depending on different population) 1. Human testing (2~10 years) of clinical investigation a. Phase 1 trials: determine what drug is effective and safe i. healthy humans at different doses ii. “College male beer money” b. Phase 2 trials: controlled studies on patients with target diseases i. Small sample size c. Phase 3 trials: controlled and uncontrolled trials to see safety and efficacy i. Population that is usually targeted ii. Sample is broader iii. Larger sample across differnet places (Duke, Emory, Harvard…) iii. Stage 3 ( FDA Approval) 1. Fill out New Drug Application (NDA) lasts 2 months – 10 years, avg: 24 months 2. Drug reviewed by FDA for safety and efficacy a. Either be approved or additional info requested i. Kicked back for more info hey bring back more info! 3. Expedited review: accelerated approval that provide benefit for serious of life- threatening illnesses (1980s people were dropping like flies with HIV.. with meds being reviewed) a. Clinical data was getting information patients receiving medication b. Cancer medication from Chemo iv. Stage 4 (post marketing Studies)
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1. Studies conducted after release to detect rare adverse drug reaction in POPULATION AT LARGE a. Largest sample: World population is the population size 2. Expousure to populations not included in premarketing trials 3. Data collected and submitted by practitioners 4. Results in black box warmings or withdrawal of drug from the market a. Ex. Biaax (COX2) having MI after it was released.. 1-800 bad drug lawyers!
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