Buxton: drug development Flashcards
pharmacy
broad discipline interested in MANUFACTURE and therapeutic management of drugs
safety pharmacology
focuses on finding side effects BEFORE drugs go on market
toxicology
adding environmental/industrial stressors to the point that does does damage
generic name
assigned to a drug (NOT BRAND.) ex, propanolo
chemical name
IUPAC name
lead drug
compound w/ greatest POTENTIAL for development… then it gets tested
official drug names
name in databases (us pharmacopia, national formulary, us adopted names)
trade name
name marketed by company
FDA
- regulates drugs for human consumption
- FDA website has recall and safety alerts
- it’s not perfect
chinese papyrus
used to treat smallpox
how many proposed chemical entities actually become drugs
1 in 10K :O
omparozol (sp?)
made an isomer that works just as well just to not waste money of drug developement
drug development timeline
don’t need to know too well, just the gist
at bench, 1-5 yrs. -then market analysis and then go through the lead finding -then pharmacologic eval: find in vitro receptor, cell assay, animal models -then select candidates -then toxicology and pharacokinetics -then select candidates
Investigational new drug app
studies chemical and biological activities; doses specified for humans; quality control; description of company facilities; scientific qualifications of investigators; specific details of protocol
clinical testing protocols
objectives, methods, controls for age gender sex and such
phase I
20-100 healthy volunteers. look for safety, beset way to administrator, evaluate how drug is metabolized… COLLEGE KIDS perfect for this
6-8mo
phase II
30-40 control and diseased subjects… 1/5 respond, then it’s considered successful. then you establish dose range. see long term toxicity
6mo-3yr
phase III
1-4 yrs. 100-1000+ volunteers suffering from condition. determine whether the drug is effective and safe
if drug is safe and effective after phase three…?
submit new drug app to FDA to approval
test fertility and long term toxcitty
phase IIIb/IV
on going time! volunteer patients. provides additional safety data, applies to broad pop. no longer blind studies
post/market studies
ongoing, months to years.
new age groups or patient types.
continues safety assurance and checks for unknown side effects
three agencies for drug development
US: FDA
European: Organization of economic cooperation and development, OECD
Japanese Agency: ministry of health labor and welfare-MHLW
GLP
Good lab practices to make sure experiments date is collected well and stuff
Thalidomide
morning sickness pill used in europe
sadly, FDA recognized that it caused severe birth defects in newbords
TGN1412
- antibody to help balance immune system’s T cells
- worked well in monkey (no observed effect level) but cause terrible cytokine storm in humans-
- things we learned: we gotta know mechanism, don’t administer simultaneuously to pts, and healty vs patients should be reevaluated
