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34 Cards in this Set
- Front
- Back
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components of protocol design
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dose selection rationale (toxicokinetics)
GMP chemistry IRB approval of protcols informed consent |
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phase 1--what does it look at?
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1) safety
2) clinical pharmcology 3) no (or rarely) efficacy also: PK, metabolism, food effect, AM/PM |
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phase 1 participants
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10-50 VOLUNTEERS
usually MALE |
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Phase 1 duration
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6mo-2yrs
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phase 1--study design
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placebo, double-blinld
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phase 2--what does it look at?
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1) efficacy
2) extended safety |
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phase 2--study design
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well-controlled, randomized placebo-controlled double blind for:
2-WEEKS - 6 MONTHS dosing! |
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phase 2 participants
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100-500 pts
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phase 2 duration
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1-2yrs
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phase 3--what does it look at?
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1) chronic extended safety
2) chronic persistent efficacy |
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phase 3--participants
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1K-10K pts
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phase 3 duration
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1-3 yrs
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phase 3
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looks at
-varied populations (gender, age, race, co-existing dx, children, smokders) |
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phase 3
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looks at:
-drug interactions |
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phase 3--study design
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placebo controlled (3-9 months), open label extension 1-2 yrs
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phase 2
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mechanistic studies
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phsae 2
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small exhaustively studied
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phase 3
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comparative to other therapies (for "claims," formularies, reimbursement)
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phase 3
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toxicology: 2 species lifetime, 1-or-2-yr dog/monkey
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when is the NDA submitted?
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after phase 3
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time between NDA submission and package insert labeling?
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6mo-12 mo
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how much time between post-marketing & phase 4 or 5?
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1-2 yrs
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phase 4
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commercial objectives
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phase 4
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marketing support studies
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phase 4
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large seeding studies
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phase 4
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comparative studies
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phase 5
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medical/scientific objectives
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phsae 5
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new indications
dose changes new formations drug interacions changes to label chemistry changes (stability) |
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upon sNDA submission, how long is the wait time for approval?
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12months
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ANDA--what is the purpose of this?
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submit this when patient expires
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discovery research--preclinical development
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2-6 yrs
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IND phase (clinical development)
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4-10 yrs
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NDA wait time
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1 yr
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total development time
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7-17 yrs (avg = 12)
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