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22 Cards in this Set
- Front
- Back
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what are the 5 phases of drug development?
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1. synthesis/discovery
2. safety evaluation 3. effectiveness evaluation 4. review of drug application 5. post-market surveillance |
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what is LD50?
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dose of drug that kills 50% of mice
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what is margin of safety?
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the LD50/ED50. should be above 2000
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How does one determine LD50?
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via a graph
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What is the purpose of short term toxicity testing?
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get the LD50, general profile of mice on drug (HR/RESP/R/CNS Seizure, muscle relaxant)
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Is this short or long term toxicity testing:
get general profile of mice taking the drug, and LD50 |
short term toxicity
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What is the purpose of long term toxicity testing?
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give daily dose to rats/dogs for a while, observe blood for toxicitites, and then kill and examine tissues
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Is this short or long term toxicity testing:
daily doses given to animal, examine blood, check for toxicity, kill animal and examine tissue |
Long term
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3 specialized animal tests
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reproduction, carcingen, teratogenicity
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what is an IND? When is it submitted? what does it invovle(6 things)?
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Investigational new drug application
submitted after STT/LTT/Specialized tests show no bad effects 1. animal data 2. protocol for human test 3. chemical structure of drug 4. synthesis of drug 5. formulation of dose form, 6. packaging info |
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Clinical trials involve 3 steps. what is the difference between 1,2,3 involving # of pts?
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1,2 have 100 pts
3 has 2000-3000 |
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Clinical trials involve 3 steps. what is the purpose of phase 1?
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establish toxicity dose
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Clinical trials involve 3 steps. what is the sample like in step 1?
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healthy males, taking single doses
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Clinical trials involve 3 steps. what is the patient sample in step 2?
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the targeted population
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Clinical trials involve 3 steps. what is the patient sample in step 3?
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larger, target, kids maybe
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Clinical trials involve 3 steps. what is the purpose of phase 2?
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establish dose reponse/range, therapeutic efficacy
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Clinical trials involve 3 steps. what is the purpose of phase 3?
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verify its efficacy
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Clinical trials involve 3 steps.
when can phase 1 begin? When can phase 3 begin? |
immediately after IND approval
after effective dose range established |
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What is phase 4 of clinical drug trials? When does it occur?
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after fda approval
collect more data in greater numbers and define side effects |
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What is an NDA? When is it submitted?
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new drug application
after 8 yrs of human/animal test |
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what is an investigational new drug? what is unique about it?
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it is released to special patients prior to FDA approval, IF NO SIDE EFFECTS
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What 3 powers does FDA have with OTC drugs?
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check for misbrand/alduteration
sets safety guidelines prevent/withdraw if necessary |
