new drug development and approval process

Question 1

what are the sources of drugs

Answer 1

Natural sources
synthesized in laboratory
processes of biotechnology

Question 2

certain major contributions to modern drug therapy may be attributed to the

Answer 2

successful conversion of botanic folklore remedies into modern wonder drugs

Question 3

tranquilizer, hypotensive agent

Answer 3

reserpine/rauwolfia serpentina

Question 4

diabetes mellitus

Answer 4

periwinkle or vinca rosea

Question 5

plants extracts of V. rosea yield 2 potent drugs for certain types of cancer (leukemia, hodgkin disease)

Answer 5

vinblastine
vincristine

Question 6

ovarian cancer

Answer 6

pacific yew tree

Question 7

mumps and influenza vaccines

Answer 7

fluid of chick embryo

Question 7

rich source of estrogen

Answer 7

urine of pregnant mares

Question 7

poliomyelitis vaccines

Answer 7

renal monkey tissue

Question 8

rubella (german measles)

Answer 8

duck embryo

Question 9

new vaccines for diseases aids and cancer

Answer 9

cell and tissue cultures

Question 9

smallpox vaccines

Answer 9

skin of bovine calves inoculated with vaccinia virus

Question 10

requires metabolic biotransformation after administration

Answer 10

prodrug

Question 11

science concerned with drugs, their sources, appearance, chemistry, actions and uses.

Answer 11

pharmacology

Question 12

this extent and rate of drug absorption from various routes of administration

Answer 12

absorption

Question 13

the rate of drug distribution of the drug through the body and the site or sites

Answer 13

distribution

Question 14

the rate, primary and secondary sites, the mechanism of the drug’s metabolism

Answer 14

metabolism

Question 15

the proportion of administered dose eliminated from the body

Answer 15

excretion/elimination

Question 16

drug substance administered by any route

Answer 16

drug’s solubility

Question 17

a measure of its distribution in a lipophilic - hydrophilic phase system

Answer 17

partition coefficient

Question 18

speed at which drug substance dissolves in a medium is called

Answer 18

dissolution rate

Question 19

reducing the particle size and increasing the powder fineness

Answer 19

physical form

Question 20

the chemical and stability of drug substance are critical to prepare a successful pharmaceutical product

Answer 20

stability

Question 21

pre-formulation studies

Answer 21

drug’s solubility
partition coefficient
dissolution rate
physical form
stability

Question 22

- healthy volunteers - 20 to 100 subjects - initial dose of drug is low - greater dose until some evidences of the drug's effect - determine the human pharmacology

Answer 22

phase 1

Question 23

- evaluate the effectiveness of a drug in patients with the condition. - uses patients as subjects - determine the pharmacokinetics of the drug

Answer 23

phase 2

Question 24

- several hundred to several thousand patients in controlled and uncontrolled trials - determine the usefulness of the drug

Answer 24

phase 3 and phase 4

Question 25

a standard or comparator drug product

Answer 25

placebo drug

Question 26

the patient is unaware of the agent administered

Answer 26

single blind studies

Question 27

neither the patient nor the clinician is aware of the agent administered

Answer 27

double blind studies

Question 28

neontal, pediatric, and geriatric patients

Answer 28

age

Question 29

doses for certain drugs are based on ______

Answer 29

body weight

Question 30

other important studies on women

Answer 30

sex

Question 31

ability to endure the influence of drug

Answer 31

tolerance

Question 32

effects of a drug may be modified by the prior

Answer 32

concomitant drug therapy

Question 33

oral therapy in relation to meals

Answer 33

time

Question 34

drugs administered intravenously enter the bloodstream

Answer 34

dosage form and route of administration

Question 35

including the proprietary and nonproprietary names

Answer 35

description of the product

Question 36

including a summary of actions of the drug in humans

Answer 36

clinical pharmacology

Question 37

including the FDA-approved indications in the treatment

Answer 37

indications and usage

Question 38

situations in which the drug should not be used

Answer 38

contraindications

Question 39

including descriptions of serious adverse reactions and potential safety

Answer 39

warnings

Question 40

including special care to be exercised by prescriber and patient in the use of the drug

Answer 40

precautions

Question 41

including predictable and potential unpredictable undesired side effects

Answer 41

adverse reactions

Question 42

including legal schedule if a controlled substance

Answer 42

drug abuse and dependence

Question 43

including signs, symptoms and laboratory findings of acute overdosage

Answer 43

overdosage

Question 44

stating the recommended usual dose

Answer 44

dosage and administration

Question 45

drug product labeling

Answer 45

adverse reactions clinical pharmacology contraindications description of the product dosage and administration drug abuse and dependence indications and usage precautions warnings overdosage precautions