28-48

Question 1

The science concerned with drugs, their sources, appearance,
chemistry, actions and uses. It includes the biochemical and
physiologic effects, mechanism of action, absorption,
distribution, biotransformation, and excretion

Answer 1

Pharmacology

Question 2

is the science that analyzes how the human body interacts with a drug.

Answer 2

Pharmacokinetics

Question 3

examines how the drug is absorbed, distributed, metabolized, and excreted
by the body.

Answer 3

Pharmacokinetics

Question 4

is the science that studies the biochemical and physiologic effects of a drug and its organ- specific mechanism of action, including effects on the cellular level.

Answer 4

Pharmacodynamics

Question 5

“what the body does to the
drug,”

Answer 5

Pharmacokinetics

Question 6

“what the drug does to
the body.”

Answer 6

Pharmacodynamics

Question 7

are used to evaluate the pharmacologic effects of the agent on
specific organ system.

Answer 7

Whole animal studies

Question 8

define further the
compound’s activity and selectivity.

Answer 8

Studies with isolated animal tissues

Question 9

are then performed to detect evidence of efficacy and to determine
whether the compound is an agonist or antagonist.

Answer 9

Compounds effect on the cell function

Question 10

for various receptors and its activity against select enzyme
systems.

Answer 10

Compound’s selectivity

Question 11

is to obtain basic information on the drugs effects that maybe safe and effective use in humans.

Answer 11

Animal Studies

Question 12

Hypertensive studies-

Answer 12

Dogs and rats

Question 13

Respiratory effects studies-

Answer 13

Dogs and Guinea pigs

Question 14

Diuretic activities-

Answer 14

Dogs

Question 15

Blood coagulation

Answer 15

Rabbits

Question 16

Central Nervous system studies-

Answer 16

Mice and rats

Question 17

involves those chemical process
within living organism to maintain life.

Answer 17

Drug metabolism

Question 18

Series of animal studies of a proposed drugs ADME are
undertaken to determine the following:

Answer 18

 Extent and rate of drug absorption from various route of
administration
 Rate of distribution of the drug through the body and the
site and duration of drug’s residence
 Rate, primary and secondary sites, mechanism of the
drug’s metabolism in the body
 Proportion of administered dose eliminated from the
body

Question 19

Participate in drug metabolism (liver, kidneys, lung & git)

Answer 19

Specific & non-specific enzymes

Question 20

What happens to Drugs following oral adm. that enter the hepatic
circulation after absorption from gut

Answer 20

Exposed to rapid drug metabolism

Question 21

transit through the liver & exposure to the
hepatic enzyme system

Answer 21

1st pass effect

Question 22

what route of adm is used for the systemic cirulation through blood bessels other than hepatic

Answer 22

Adm of buccal and rectal

Question 23

performed through the collection &
analysis of urine, blood & feces samples, & careful exam. Of animal tissues & organs upon autopsy

Answer 23

ADME studies

Question 24

Deals with the adverse or undesired effects of drugs

Answer 24

Toxicology

Question 25

Preclinical safety evaluation or toxicity studies

Answer 25

toxicology

Question 26

enumerate what to determine in toxicology

Answer 26

 Substance’s potential for toxicity with short-term or long- term use  Substance’s potential for specific organ toxicity  Mode, site and degree of toxicity  Dose-response relationships over time  Gender, Reproductive or teratogenic toxicities  Substance’s carcinogenic and genotoxic potential

Question 27

toxic effect of a test compound when administered in single dose and/or multiple doses over short period, usually a single day.

Answer 27

Acute or short-term toxicity studies

Question 28

find doses that do not to produce toxic effect, severe toxic effect & intermediate toxic level

Answer 28

doses are ranged

Question 29

The relationship to projected human clinical studies for safety

Answer 29

Subacute or subchronic studies

Question 30

how much is the minimum of drug administration of aniaml toxicity studies and dosage level

Answer 30

two weeks daily and 3 or more dosage levels

Question 31

drugs intended to be given to humans for a week or more, animal studies of 90 to 180 days in length must demonstrate safety

Answer 31

Chronic toxicity studies

Question 32

How long is the animal studies for chronic human illness

Answer 32

1 year or longer

Question 33

For limited no. of rat & mouse strains

Answer 33

Carcinogenicity studies

Question 34

with surviving animals killed & studied at defined weeks during the test period

Answer 34

Long term studies

Question 35

how long does long term studies last?

Answer 35

18-24 months

Question 36

undertaken when the compound has shown sufficient promise as a drug to enter human clinical trials.

Answer 36

Component of chronic testing

Question 37

reveals any effect of an active ingredient on mammalian reproduction

Answer 37

Reproduction studies

Question 38

Evaluated for anatomical abnormalities, growth & development: maternal parent, fetus, neonates & weaning offspring

Answer 38

Reproduction studies

Question 39

Fertility & mating behavior, mutagenicity, teratology

Answer 39

Reproduction studies

Question 40

Determines whether test compd affects gene mutation or cause chromosome or DNA damage

Answer 40

Genotoxicity or Mutagenicity Studies

Question 41

Used in assays to detect mutations: Strains of Salmonella typhimurium

Answer 41

Genotoxicity or Mutagenicity Studies

Question 42

Each drug substance has intrinsic chemical and physical characteristics that must be considered before the development of a pharmaceutical formulation

Answer 42

Preformulation studies

Question 43

Enumerate what are studied at preformulation studies

Answer 43

Drug solubility Partition Coefficient Dissolution Rate Physical Form Stability

Question 44

A drug substance administered by any route must possess some aqueous solubility for systemic absorption and therapeutic response

Answer 44

Drug Solubility

Question 45

may exhibit incomplete, erratic, and/or slow absorption thus produce minimal response at desired dosage

Answer 45

Poor soluble compounds

Question 46

is a measure of its distribution in a lipophilic- hydrophilic phase system and indicates its ability to penetrate biologic multiphase system

Answer 46

Drug's Partition Coefficient

Question 47

It is the speed at which a drug substance dissolves in a medium

Answer 47

Dissolution Rate

Question 48

The crystal or amorphous forms and/ or the particle size of a powdered drug can affect the dissolution rate, thus the rate and extent of absorption, for a number of drugs

Answer 48

Physical Form

Question 49

testing at various temperature, conditions of relative humidity (RH), durations, and environments of light, air and packaging is essential in assessing drug and drug product stability

Answer 49

Stability