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34 Cards in this Set

  • Front
  • Back
components of protocol design
dose selection rationale (toxicokinetics)
GMP chemistry
IRB approval of protcols
informed consent
phase 1--what does it look at?
1) safety
2) clinical pharmcology
3) no (or rarely) efficacy

PK, metabolism, food effect, AM/PM
phase 1 participants
usually MALE
Phase 1 duration
phase 1--study design
placebo, double-blinld
phase 2--what does it look at?
1) efficacy
2) extended safety
phase 2--study design
well-controlled, randomized placebo-controlled double blind for:

2-WEEKS - 6 MONTHS dosing!
phase 2 participants
100-500 pts
phase 2 duration
phase 3--what does it look at?
1) chronic extended safety
2) chronic persistent efficacy
phase 3--participants
1K-10K pts
phase 3 duration
1-3 yrs
phase 3
looks at
-varied populations (gender, age, race, co-existing dx, children, smokders)
phase 3
looks at:
-drug interactions
phase 3--study design
placebo controlled (3-9 months), open label extension 1-2 yrs
phase 2
mechanistic studies
phsae 2
small exhaustively studied
phase 3
comparative to other therapies (for "claims," formularies, reimbursement)
phase 3
toxicology: 2 species lifetime, 1-or-2-yr dog/monkey
when is the NDA submitted?
after phase 3
time between NDA submission and package insert labeling?
6mo-12 mo
how much time between post-marketing & phase 4 or 5?
1-2 yrs
phase 4
commercial objectives
phase 4
marketing support studies
phase 4
large seeding studies
phase 4
comparative studies
phase 5
medical/scientific objectives
phsae 5
new indications
dose changes
new formations
drug interacions
changes to label
chemistry changes (stability)
upon sNDA submission, how long is the wait time for approval?
ANDA--what is the purpose of this?
submit this when patient expires
discovery research--preclinical development
2-6 yrs
IND phase (clinical development)
4-10 yrs
NDA wait time
1 yr
total development time
7-17 yrs (avg = 12)