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8 Cards in this Set
- Front
- Back
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what are 2 ways an OTC med can be FDA approved
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1) an NDA
2) a OTC monograph process- basically a recipe book of meds that are already approved via NDA process |
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how many phases are there in implementing a new drug
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4
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what is purpose of phase 1
subjects used? size of trial and length of trial? |
safety profile, usually healthy patients,
20-80 patients usually 6-12 months |
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purpose of phase II
subjects? size and length of trial? |
safety and efficacy-usually has 3 or 4 arms trying to fig best dosage
used in the intended target population 100-300 patients 1-2 years |
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purpose of phase III
subjects? size and length of trial? |
safety and efficacy at dose and schedule seeking approval- must obtain FDA approval prior to this phase starting
IIIb- post NDA submission looking at additional indications used in target pop 2-3 years, hundred to thousands of patients |
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what happens after phase III
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Manu files for a NDA, once filed the FDA has 1 year to decide
can decided for it to be approved, denied, or need more info |
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phase IV
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post-marketing trials
SE or ADRs not seen in trials because sample size was so small ( like Craigs little dick) and determine long term effects |
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what must manu file to make a change to an existing drug
name examples of changes |
SNDA- supplemental New Drug Application
labeling changes new dose new strength new manu process |
