Introductory Concepts

Question 1

true or false: a drug includes devices or their component parts or accessories

Answer 1

false

Question 2

majority of drugs are of this chemical nature

Answer 2

weak acids and bass

Question 3

majority of drugs available in the market are between ___ in size

Answer 3

10-1000 MW

Question 4

the higher the generation, the more gram (-)/(+)?

Answer 4

(-)

Question 5

This states that every physician should prescribe a drug in its generic name; the brand name is optional

Answer 5

Generic Act of 1988 (RA 6675)

Question 6

[branch of pharma] involved in compounding, preparation, collection, standardization and dispensing of drugs (health service profession)

Answer 6

pharmacy

Question 7

[branch of pharam] recognizing the drug; study of crude drugs and the identification of their sources

Answer 7

pharmacognosy

Question 8

[branch of pharma] studies the structure activity relationship (SAR) of a drug

Answer 8

biochemorphology

Question 9

Norepinephrine affects which receptors?

Answer 9

a1, a2, B1

Question 10

Epinephrine affects which receptors?

Answer 10

a1, a2, B1, B2

Question 11

Isoproterenol affects which receptors?

Answer 11

B1, B2

Question 12

[branch of pharma] study of drug’s adverse effects

Answer 12

toxicology

Question 13

how many tablets of paracetamol can be consumed per day before hepatotoxicity?

Answer 13

<8

Question 14

antidote to Paracetamol poisoning

Answer 14

N-acetylcysteine

Question 15

antidote to INH poisoning

Answer 15

pyridoxine

Question 16

[branch of pharma] deals with dosage of drug needed to produce a therapeutic effect

Answer 16

posology

Question 17

dosage usually given to elderlies and why

Answer 17

1/2 of adult dose because of slow metabolism

Question 18

what to keep in mind when giving dosage in pedia

Answer 18

compute for dose for kg body weight

Question 19

[branch of pharma] studies mechanism of action at the enzymatic level

Answer 19

molecular pharmacology

Question 20

under molecular pharmacology, concerned with insertion, alteration, or removal of a gene to treat a disease

Answer 20

gene therapy

Question 21

under molecular pharmacology, concerned with insertion of an artificial gene and making use of biotechnology to produce biopharmaceuticals that improve genetic make-up

Answer 21

genetic engineering

Question 22

[branch of pharma] deals with drugs given to the mother as it affects the fetus

Answer 22

developmental pharmacology

Question 23

true or false: there is no safe drug for pregnant women

Answer 23

true

Question 24

ACE inhibitors can be given until which trimester only and why

Answer 24

until 1st trimester only because it inhibits urine production for the fetus

Question 25

effect of isotretinoin on the fetus

Answer 25

mental retardation, cleft lip, ear and eye defect

Question 26

which vitamin could cause mental retardation in a fetus?

Answer 26

vitamin A (high dosage)

Question 27

[branch of pharma] considers influence of heredity on the effect of drugs

Answer 27

pharmacogenetics

Question 28

asians are fast or slow acetylators? and what does this mean?

Answer 28

FAST acetylators therefore drugs are more water soluble

Question 29

[branch of pharma] considers the use of genetic information to guide the choice of therapy or which drug variations produce certain response

Answer 29

pharmacogenomics

Question 30

[branch of pharma] studies response of a population to a drug and is used to detect and monitor adverse or beneficial effects

Answer 30

pharmacoepidemiology

Question 31

[branch of pharma] cost-effectiveness and follows rational use of drug (ESSC)

Answer 31

pharmacoeconomics

Question 32

[branch of pharma] studies interethnic differences in responses, presence of absence of enzymes, and comparing the use of traditional vs modern drugs

Answer 32

ethnopharmacology (pharmacoanthropology)

Question 33

[branch of pharma] deals with the rational development of drugs, and their safe and effective use and proper evaluation

Answer 33

clinical pharmacology (pharmacotherapeutics) / clinical or applied therapeutics

Question 34

ESSC Criteria

Answer 34

Efficacy, Safety, Suitability, Cost

Question 35

what BODY does to the drug/ fate of drug in the body

Answer 35

pharmacokinetics

Question 36

4 processes involved in pharmacokinetics

Answer 36

(ADME) Administration, Distribution, Metabolism, Excretion

Question 37

main distributor of the drug

Answer 37

blood

Question 38

major organ for metabolism of the drug

Answer 38

liver

Question 39

sites of absorption

Answer 39

stomach and SI

Question 40

major excretory organ

Answer 40

kidney

Question 41

other excretions via:

Answer 41

lungs, skin, bile, saliva

Question 42

route of pharmacokinetics

Answer 42

administration --> systemic circulation --> target organ --> effect

Question 43

what DRUG does to the body/ involves MOA (enzymatic or molecular level)

Answer 43

pharmacodynamics

Question 44

pharmacodynamics can be observed once drug reaches what point?

Answer 44

target area

Question 45

6 Stages of Drug Development

Answer 45

1) Animal Testing 2) FDA - file IND app 3) Clinical Testing (first 3 phases) 4) Product Development 5) New Drug Application 6) Post Marketing Surveillance (PMS) / 4th phase of clinical testing

Question 46

animal testing determines toxicity. Define acute, subacute and chronic toxicity

Answer 46

Acute: 7-14 days Subacute: 2wks-3mos Chronic: 6mos- 2yrs

Question 47

duration of animal testing

Answer 47

1-3 years

Question 48

safety review is conducted by the FDA for how long

Answer 48

30 days

Question 49

what application do u submit to the FDA before the drug can proceed to human clinical trials?

Answer 49

Investigational New Drug (IND) application

Question 50

duration of human clinical trials

Answer 50

2-10 years (ave: 5-6 yrs)

Question 51

phases of clinical testing

Answer 51

1 - safety 2- efficacy and dose 3 - verify efficacy and detect ADRs 4 - additional data after approval

Question 52

sample needed per phase of the clinical trial

Answer 52

1 - healthy adult (20-80) 2- selected patients (100-300) 3 - large sample of selected patients (1000-3000) 4 - general population?

Question 53

who conducts each phase of the clinical trial

Answer 53

1&2: clinical pharmacologist 3: clinical investigators 4: all physicians

Question 54

average time for product development

Answer 54

12 years

Question 55

how many compounds are evaluated, how many enter the trials and how many are approved?

Answer 55

5,000 compounds evaluated 5 enter trials 1 approved

Question 56

stage of drug development where additional data are obtained, as well as product defect reporting, product line extensions, and chronic effects

Answer 56

Post Marketing Surveillance (PMS)

Question 57

this is used to achieve blindness and subjective bias

Answer 57

placebo

Question 58

enhances or depresses NON-specialized tissues

Answer 58

irritation

Question 59

variables involved in drug activity

Answer 59

1) pharmaceutical phase (disintegration and dissolution) 2) pharmacokinetic phase (bioavailability) 3) pharmacodynamic phase (individual sensitivity, drug-drug interactions, pathological conditions) 4) Effects (toxic, therapeutic, subtherapeutic)

Question 60

refers to the fraction of the drug that remained unchanged reaching the systemic circulation

Answer 60

bioavailability

Question 61

bioavailability via IV vs orally; why?

Answer 61

IV: 100% (bypasses the liver) orally: 5-10% (first-pass effect) synthetic or non-synthetic