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Pharm Chp 3
| Question | Answer |
|---|---|
| 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 |
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