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Pharm Chp 3

QuestionAnswer
All drugs are required to be proven effective against what? Effective compared ot an inactive placebo, not compared to other drugs
How are the 5 schedules of drugs ordered? In decreasing order of potential for addiction and abuse. (Ex. 1= no medical use Heroin, LSD, 2. Useful medication but high addiction potential (morphine, cocaine, amphetamines)
What was the purpose behind fast tracking drugs? Acceleration of approval process if need deemed urgent (Aids Cancer etc, no options)
Broader guideline from the FDA allowed for for what group(s) to be added into clinical studies? Women and patients from minority populations
Do manufactures have to have a plan for patients if they choose to discontinue a product? Yes
What is a "off Label" promotion? Drug being used to treat something other than what is specifically indicated for
How long is the FDA able to surveille a drug for safety? After the post morketing phase and beyond
What are the stages of drug development? Preclinical testing and Clinical testing
Can a drug be tested on humans prior to preclinical testing? No
What are the drugs evaluated for in preclinical testing? Toxicities, pharmacokinetic properties, potentially useful biologic effect
How many phases are there in Clinical testing? Four
What takes place in phase 1? NORMAL volunteers, evaluate drug metabolism, effects on humans
What happens in Phase II? Tested on Real Patients, Determine therapuetic effects, Dosage ranges
What happens in Phase III? Patient safety + effectiveness, Only have to use UPTO 5000 subjects, conditional approval
What happens in Phase IV? Postmarketing surveillence, Use in general population, ongoing surveillence of safety
What is unique about dietary supplements? They do not require proof of efficacy or safety
What are the types of drugs by regulatory authority? Legend or prescription (Rx) only - FDA, Over-the-Counter (OTC) - FDA, Behind-the-Counter = requires that you talk with a pharmacist (Nicotine containing cessasation, plan B, psuedoephedrine), Nutritional/dietary supplements - DSHEA
What type of drugs are vitamins? Some are Rx, some OTC, and some dietary supplements
What groups are still excluded from clinical trial? Pregnant or breast feeding, chronic disease, chronic organ system dysfunction, elderly, obese
What are different types of drug names? Investigational number, chemical name, generic name (Universal), abbreviation, trade name
What is a major issue with drug names? Multiple brand names for what are DIFFERENT products and/or have DIFFERENT ingredients
How do generics compare to brand names? Usually generic products are equivalent to brand name products; very few exceptions
What does a Monoclonal antibody product do? Blocks an antigen from working
What in the ending in monoclonal antibody drugs? MAB
How does the name for monoclonal drugs break down? A unique prefix, a 2-3 abbreviation that relates to clinical application(target or disease), Source (human, humanized etc), mab
What are the source abbreviations? Human= U, Humanized = ZU, Chimeric = XI, Primate = I, Mouse = O, Rat = A, Hamster = E
What are the disease or target abreviations? Colon Tumor= COL, Melanoma= MEL, Breast Tumor = MAR, Testicular = GOT, Ovarian= GOV, PRO= PRO, Miscellaneous tumor= TUM, Viral= VIR, Bacterial=BAC, Infectious lesion=LES, Immune=LIM, Cardiovascular= CIR
Created by: zj mepn