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RENAL II Exam 1 > Clinical Drug Trials > Flashcards

Flashcards in Clinical Drug Trials Deck (29):
1

clinical trials

4 phases

2

FDA approval

after three phases of clinical trials

3

1906

federal pure food and drugs act
-modern era of FDA begins

4

1962

FDA required proof of efficacy

5

rational drug design

based on bio mechanisms, drug receptor structure, and drug structure

6

lead compound

chemical compound that has pharm or bio activity and whose chem structure is used as starting point for chemical modifications in order to improve potency, selectivity, or pharmacokinetic parameters

7

preclinical safety

estimate risk associated with drug exposure

8

acute toxicity

two species, two routes
-no effect dose and max tolerated dose

9

subacute toxicity

three doses, two species
-2 weeks to 3 months

10

chronic toxicity

rodent and nonrodent for > 6 months
-

11

effect on repro performance

two species
-effects on mating behavior, birth defects, etc.

12

carcinogenic potential

two years, two species

13

mutagenic potential

genetic stability and mutations in bacteria or mammalian cell cultures

14

investigative toxicology

determine sequence and mechanisms of toxic action

to discover genes, proteins, pathways involved

15

no effect dose

maximum dose at which toxic effect not seen

16

minimum lethal dose

LDmin
-smallest dose observed to kill experimental animal

17

median lethal dose

LD50
-dose that kills 50% of animals

18

limitations to preclinical testing

-cost and time
-number of animals used
-extrapolation of values to human system

19

crossover design

patients receiving each therapy in sequence so patients serve as own controls

20

single blind study

only health professionals know identity of treatment

21

double blind study

neither patient or health professional know identity of therapy
-third party holds code identification of medication and clinical data

22

investigational new drug

means by which investigators obtain permission from FDA to proceed with drug distribution

IND - commercial and non-commercial

23

institutional review board

IRB - assure appropriate steps are taken to protect rights safety and welfare of humans participating in research

24

phase 0

microdosing
-subpharm doses administered to humans

toxicology safety testing

low cost

25

phase 1

first stage of drug testing in humans

-to determine difference in humans and animals
-also establish limits of safe clinical range

health individuals

absorption, half-life, and metabolism

26

phase 2

small group of patients with target disease (100-200)

efficacy, dose requirements, and toxicities

single blind

27

phase 3

after effectiveness, dose, and toxicity determined

to further establish drug safety - large group of patient (300-3,000)

crossover and double blind

evaluate overall benefit-risk ration of drug

most expensive

28

new drug application

by manufacture to FDA for license to market the drug for specified indication

after completion of phase 3 trials (typically)
-unless serious disease (still in phase 3) or life-threatening (still in phase 2)

29

phase 4

begins after approval to market drug

post marketing study with purpose to continue to monitor safety of new drug under actual conditions in large number of patient