Buxton: drug development

Question 1

pharmacy

Answer 1

broad discipline interested in MANUFACTURE and therapeutic management of drugs

Question 2

safety pharmacology

Answer 2

focuses on finding side effects BEFORE drugs go on market

Question 3

toxicology

Answer 3

adding environmental/industrial stressors to the point that does does damage

Question 4

generic name

Answer 4

assigned to a drug (NOT BRAND.) ex, propanolo

Question 5

chemical name

Answer 5

IUPAC name

Question 6

lead drug

Answer 6

compound w/ greatest POTENTIAL for development… then it gets tested

Question 7

official drug names

Answer 7

name in databases (us pharmacopia, national formulary, us adopted names)

Question 8

trade name

Answer 8

name marketed by company

Question 9

FDA

Answer 9

• regulates drugs for human consumption
• FDA website has recall and safety alerts
• it’s not perfect

Question 10

chinese papyrus

Answer 10

used to treat smallpox

Question 11

how many proposed chemical entities actually become drugs

Answer 11

1 in 10K :O

Question 12

omparozol (sp?)

Answer 12

made an isomer that works just as well just to not waste money of drug developement

Question 13

drug development timeline

don’t need to know too well, just the gist

Answer 13

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

Question 14

Investigational new drug app

Answer 14

studies chemical and biological activities; doses specified for humans; quality control; description of company facilities; scientific qualifications of investigators; specific details of protocol

Question 15

clinical testing protocols

Answer 15

objectives, methods, controls for age gender sex and such

Question 16

phase I

Answer 16

20-100 healthy volunteers. look for safety, beset way to administrator, evaluate how drug is metabolized… COLLEGE KIDS perfect for this

6-8mo

Question 17

phase II

Answer 17

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

Question 18

phase III

Answer 18

1-4 yrs. 100-1000+ volunteers suffering from condition. determine whether the drug is effective and safe

Question 19

if drug is safe and effective after phase three…?

Answer 19

submit new drug app to FDA to approval

test fertility and long term toxcitty

Question 20

phase IIIb/IV

Answer 20

on going time! volunteer patients. provides additional safety data, applies to broad pop. no longer blind studies

Question 21

post/market studies

Answer 21

ongoing, months to years.
new age groups or patient types.
continues safety assurance and checks for unknown side effects

Question 22

three agencies for drug development

Answer 22

US: FDA
European: Organization of economic cooperation and development, OECD
Japanese Agency: ministry of health labor and welfare-MHLW

Question 23

GLP

Answer 23

Good lab practices to make sure experiments date is collected well and stuff

Question 24

Thalidomide

Answer 24

morning sickness pill used in europe

sadly, FDA recognized that it caused severe birth defects in newbords

Question 25

TGN1412

Answer 25

• 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