General Principles of Pharmacology

Question 1

what is pharmacology

Answer 1

study of drugs

formulation of drugs

Question 2

what are drugs

Answer 2

any substance that alter physiologic mechanisms

Question 3

pharmacy

Answer 3

only the ones that can dispense drugs

Question 4

pharmaceutical company

Answer 4

business side of drugs

Question 5

what is pharmokokinetics

Answer 5

what the body does to drugs

dose administered to systemic circulation

Question 6

bioavailability

Answer 6

how much of dose is in systemic or site of action

Question 7

what is drug distribution

Answer 7

drugs for lungs can also be on other areas

Question 8

what is drug clearance

Answer 8

before reaching target site some of the drugs are already metabolized or excreted

Question 9

what is phamakodynamics

Answer 9

what the drug does to body

pharmacologic effect = efficacy vs toxicity

Question 10

what is chemical name

Answer 10

chemical composition/strucutre

Question 11

generic or non-proprietary or official name

Answer 11

from US adopted names council

Question 12

trade or proprietary name

Answer 12

own name of company that is renewable every 10 yrs

Question 13

exp drug discovery in chemical modification

Answer 13

minoxidil rlly anti HTN but has side effect of hair growth

reformulated as drug for baldness

Question 14

exp drug discovery in biologic mech

Answer 14

check what are the receptors or process and the effect of drugs

antihistamine

antacid

chemo

Question 15

exp drug discovery in screening of natural products

Answer 15

lagundi leaves is natural but FDA approved as anit-cough

Question 16

final authority in approving drugs in the Philippines

Answer 16

FDA

exp should be reg and approved in FDA

Question 17

compare food supp and drugs in FDA

Answer 17

supp - FDA reg

drugs - FDA reg and approval

Question 18

phases of preclinical safety and toxicity testing

Answer 18

preclinical = animals

1. pharmacologic profile test
2. toxicity testing

Question 19

discuss pharmacologic profile testing

Answer 19

molecular - molecular level or receptors

cellular - cells in alveoli of lung

systems/disease model - lung system

Question 20

discuss toxicity testing - acute toxicity

Answer 20

1 dose

1-2 routes

2 species

2 wks

Question 21

discuss toxicity testing - subacute toxicity

Answer 21

repeated doses

same route

2 wks to 2 mo

2 species

Question 22

discuss toxicity testing - chronic toxicity

Answer 22

repeated doses

same route

90 days

Question 23

discuss toxicity testing - effect in reproductive performance

Answer 23

see if low sperm in male rats or no pregnacny/ovulate

Question 24

discuss toxicity testing - teratogenicity

Answer 24

effect on pregnant rats - birth defects

Question 25

discuss toxicity testing - carcinogenicity

Answer 25

cells of rats if they become cancer cells

Question 26

discuss toxicity testing - mutagenicity

Answer 26

next gen of offspring depite 1st gen being normal

Question 27

discuss toxicity testing - investigative toxicity

Answer 27

other rare ways it can be toxic

Question 28

discuss thalidomide

Answer 28

used for morning sickness = amelia and phocomelia teratogenic and mutagenic

Question 29

no effect dose

Answer 29

max dose s toxic effect

Question 30

minimum lethal dose

Answer 30

smallest dose that can kill any anima

Question 31

median lethal dose

Answer 31

LD50 dose that kills approx 50% of animals

Question 32

considerations on human testing

Answer 32

1. natural hx and course of disease 2. presence of other disease and risk factors 3. subject and observer bias

Question 33

after clinical testing what should pharma companies do

Answer 33

apply for IND 1. drug info 2. manufacturing info 3. data from animal studies 5. names and credentials of doctors

Question 34

what is the word medical assoc declaration of helsinki significance

Answer 34

true written and informed consent before participation true meaning that participant understood what will happen and side effects

Question 35

phase 0

Answer 35

some FDA do no require; exploratory and fproof of concept subtherapeutic dose 10-20 normal humans 1 wk

Question 36

phase 1

Answer 36

non-blind 20-100 healthy or c target disease in facility 1-2 yrs 1/10 to 1/100 of no effect dose

Question 37

phase 2

Answer 37

single blind placebo or gold standard 100-1000 c matched demog up to 2 yrs

Question 38

phase 3

Answer 38

double blind and cross over > 1000 c condition 2-3 yrs

Question 39

discuss new drig appli

Answer 39

if NDA is approved proceed to phase 4

Question 40

phase 4

Answer 40

in market post marketting surveilance report low side effects no fixed duration

Question 41

prescription or legend drugs

Answer 41

need prescription antibiotics

Question 42

non-prescription or OTC

Answer 42

no prescription common drugs

Question 43

regulated drugs

Answer 43

special prescription pad - S2 license opioids