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Flashcards in Pharm 6 Deck (77)
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1

which drugs are poison

all - they all have the potential to produce harmful and beneficial effects

2

new drugs are gotten from

natural sources or synthesized

3

sequence of drug development

discovery/characterization of drug,
experimental animal studies,
IND application,
Clinical studies (phase I, II, III),
submission of NDA,
approval of NDA,
post marketing surveillance (Phase IV)

4

types of studies

animal studies and clinical trials

5

experimental animal studies (pre-clinical) ascertain

beneficial/harmful effects on vital organs,
elucidate the mechanism of action,
determine the pharmacokinetics

6

Animal toxicity testing

tests for teratogenicity, mutagenicity, carcinogenicity:
acute,
subacute,
chronic

7

acute toxicity

single does, to calculate TI (LD50/ED50)

8

subacute toxicity

3 doses, 4weeks to 3 months

9

chronic toxicity

6 months

10

investigational new drug application (IND)

an application for investigational new drug (IND) must have been approved by the FDA before the drug can be distrubuted for conducting clinical studies in human subjects

11

Clinical trials

once IND is approved by FDA, testing on humans canbe divided into 3 phases before approval of general marketing of the new drug for the prescription use

12

4th phase of study follws

NDA approval - phase 4 is a surveillance/observation of patients taking these drugs and monitor adverse effects

13

volunteers of clinical trials must give

written infomrmed concent (from patients or legal guardians of patients)

14

clinical trials should be conducted in conformity with

helsinki declaration

15

Phase I consists of

carful evaluation of safety in a small number of healthy volunteers (25-50)

16

phase 1 determines

whether humans and animals show significantly different responses to the durgs

17

phase 1 establishes

the probable limits of the safe clinical dosage range

18

Phase 1 can be conducted

nonblind or open (both investigator and subjects know what drug is administered)

19

Phase 1 often measures

pharmokinetics - absorption, half-life, and metabolism

20

Phase 2 involves

evaluation of a drug in a moderate number of patients ( approx. 200) with the target disease

21

Phase 2 types of studies

single or double blind with an inert substance (placebo) or an older active drug (positive control) in addition to the investigational agent

22

Phase 2 goal

to determine the desired therapeutic effect at the doses that are tolerated by the patients

23

Phase 3 consists of

large design involving many pateins ( approx. 5000)

24

Phase 3 study incudes

placebo or positive controls in double blind corssover design

25

Phase 3 goal

compare efficacy and safety with older drugs, explore spectrum of beneficial effets of new drug and to discover toxicity

26

NDA (new drug application) approval occurs

when phase 3 meets expectation of the FDA to market the new agent

27

NDA contains

hundred volumes of reports of all preclinical and clinical data pertaining to the durg under review

28

How long does FDA review

may take 3yrs or longer,
may be greatly accelerated if there is an urgent need (cancer, chemotherapy, AIDS)

29

Phase 4

post marketing surveillance

30

Phase 4 is done to

monitor safetly in pateint population and represents the phase of evaluation in which the toxicities that occur very infrequently are detected and reported to prevent major disaster