1) Introduction and Drug Discovery

Question 1

Terminology : The study of the source, physical and chemical properties, compounding, physiological actions, absorption, fate, and excretion, and therapeutic use of drugs.

Answer 1

PHARMACOLOGY

Question 2

Term: substance intended for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease

Answer 2

Drug

Question 3

term: the branch of pharmacology that studies the kinetics of drug
absorption, distribution, metabolism and excretion

Answer 3

Pharmacokinetics

Question 4

term: the branch of pharmacology that studies the biochemical,
cellular, and physiological effects of drugs and their mechanisms of action

Answer 4

Pharmacodynamics

Question 5

Term: the branch of pharmacology that studies the undesirable effects of drugs
on living systems, from individual cells to humans to complex ecosystems

Answer 5

Toxicology

Question 6

Term: the process by which a new drug is identified and brought to medical practice

Answer 6

Drug discovery

Question 7

Steps of drug discovery (4)

Answer 7

In vitro studies
Animal testing
Clinical testing
Marketing

Question 8

In in vitro studies, biologic products undergo chemical synthesis and optimization to result into a ____ (LC)

Answer 8

Lead Compound

Question 9

How many years on average does in vitro studies take?

Answer 9

2 Years

Question 10

What is the role of animal testing?

Answer 10

For finding the efficacy, selectivity, and mechanism of the Lead Compound

Question 11

After Animal testing, an Investigational New Drug is Filed, True or False?

Answer 11

True

Question 12

What is the purpose of phase 1 in clinical testing? (hm subjects + purpose)

Answer 12

20-100 subjects, to conclude its safety and pharmacokinetics.

Question 13

What is the purpose of phase 2 in clinical testing? (hm subjects + purpose)

Answer 13

100-200 subjects, To find if it works on patients.

Question 14

What is the purpose of phase 3 in clinical testing? (hm subjects + purpose)

Answer 14

1000-6000 subjects, to conclude if IND works, and double blind

Question 15

What is researched in clinical testing? (DM + SA)

Answer 15

Drug metabolism and Safety Assessment

Question 16

How many years is Clinical testing?

Answer 16

4 to 5 years

Question 17

After which step of drug development is a NDA or New drug Application filed?

Answer 17

After Clinical Testing

Question 18

How many years after filing new drug application is generics prohibited after drug discovery marketing?

Answer 18

20 years

Question 19

During drug discovery, The number of chemical entities increases from in vitro to marketing, True or False?

Answer 19

False, The number of entities decreases from thousands to one in the marketing phase.

Question 20

How do you start the drug discovery process?

Answer 20

1. screening for biologic activity of natural products, banks of previously discovered
   chemical entities, or libraries of organic molecules;
2. chemical modification of a known active molecule (“me-too” analog);
3. identification or elucidation of a new drug target (the pathophysiologic process or
   substrate of a disease); and
4. rational design of a new molecule based on an understanding of biologic
   mechanisms and drug receptor structure

Question 21

Term: Involves assays at the molecular, cellular, organ system, and whole animal levels; and aims to define the pharmacologic profile of the compound

Answer 21

Drug Screening

Question 22

Term: Results in a lead compound (ie, a leading candidate for a successful new drug)

Answer 22

Drug Screening

Question 23

Animal testing type of test : 2 species, 2 routes, determine no effect and maximum tolerated dose, determine acute dose lethal in 50% of animals

Answer 23

Acute Toxicity

Question 24

Animal testing type : 3 doses, 2 species; 2 weeks-3months of testing before clinical trials. determine biochemical + physiologic effects

Answer 24

Subacute or Subchronic Toxicity

Question 25

Animal testing type: Test rodent and >1 non-rodent species for > 6 months. It is required when drug is intended to be used in humans for prolonged periods. usually run concurrently with clinical trials. same endpoints as subacute

Answer 25

Chronic toxicity

Question 26

Animal testing type: Tests on two species, usually one rodent and rabbits. test effects on mating behavior, reproduction, parturition, progeny, birth defects, postnatal development

Answer 26

Effect on reproductive performance

Question 27

Animal testing type: Two years, 2 species. required when used in humans for prolonged periods, determine gross and histologic pathology.

Answer 27

Carcinogenic potential

Question 28

Animal testing type: Test effects on genetic stability and mutations in bacteria ( Ames test) or mammalian cells in culture; dominant lethal test and clastogenicity in mice

Answer 28

Mutagenic Potential

Question 29

Term, animal testing: Maximum dose at which a specified toxic effect is not seen

Answer 29

no effect dose

Question 30

term, animal testing: smallest dose observed to kill any experimental animal

Answer 30

Minimum Lethal Dose

Question 31

Term, Animal testing: dose that kills 50% of animals in a test group

Answer 31

Median lethal dose (LD50)

Question 32

Term: Filed with the Food and Drug Administration (FDA) before clinical test

Answer 32

INVESTIGATIONAL NEW DRUG (IND)

Question 33

INVESTIGATIONAL NEW DRUG (IND) must contain the following:

Answer 33

(1) the composition and source of the drug, (2) chemical and manufacturing information, (3) all data from animal studies, (4) proposed plans for clinical trials, (5) the names and credentials of physicians who will conduct the clinical trials, and (6) a compilation of the key preclinical data relevant to study of the drug in humans.

Question 34

Which phase in clinical trial has highest rate of drug failures, and only 25% of innovative drugs move on to phase 3

Answer 34

phase 2

Question 35

Phase 1 has 20-100 healthy subjects, true or false?

Answer 35

true

Question 36

phase 2 of clinical trials caters to 100-200 healthy subjects, true or false?

Answer 36

false, From phase 2 all subjects have target disease.

Question 37

What is the design of phase 3?

Answer 37

Randomized Controlled Trial (RCT)

Question 38

What type of blinding in RCT is when subjects do not know the intervention they received?

Answer 38

single blind

Question 39

What type of blinding in RCT is when subjects and investigators both do not know the intervention received by subjects

Answer 39

double blind

Question 40

This is filed with the FDA before marketing step; It must contain full reports of all preclinical and clinical data pertaining to the drug under the review

Answer 40

NEW DRUG APPLICATION (NDA)

Question 41

term: It Allows one pharmaceutical company to have exclusive right to market the drug Expires 20 years after application After expiration, other pharmaceutical companies can file Abbreviated New Drug Application (ANDA) to market generic products

Answer 41

Patent

Question 42

Treatment for rare diseases Difficult to research (small number of subjects) Low marketing value

Answer 42

Orphan Drugs

Question 43

The orphan drug amendment of 1983 in USA provides incentives for the development of drugs for treatment of a rare disease or condition defined as any disease or condition which affects <200,000 persons in the USA. True or False?

Answer 43

True