Drug Development Process And Application

Question 1

Microbes resist the effects of the drug making them stronger and harder to eradicate.

Answer 1

Antimicrobial Resistance

Question 2

cancer cells survive and grow despite anti-cancer therapies.

Answer 2

Antineoplastic resistance

Question 3

Examples of conditions with no treatment

Answer 3

AIDS, Polio, Multiple Sclerosis

Question 4

Role of Pharmaceutical Research Companies in the Development of New Drugs.

Answer 4

-Understand a disease
-Identify targets
-Formulate drugs that will affect the targets

Question 5

Tuseran forte contains:

Answer 5

Dextromethorphan - Antitussive
Phenylpropanolamine - Decongestant
Paracetamol - Antipyretic

Question 6

Tuseran Night Contains:

Answer 6

Diphenhydramine - Antihistamine (Allergies)
Phenylpropanolamine - Decongestant

Question 7

means by which a drug enters the body

Answer 7

Route of administration

Question 8

Give example of route of administration

Answer 8

Oral, Parenteral, topical

Question 9

Describes the physical form in which medication will be delivered into the body

Answer 9

Dosage form

Question 10

The basis or standard in drug development

Answer 10

Goal drug

Question 11

invasive meaning no break in the skin is created safe from infections, convenient, not humiliating or offensive to the patient

Answer 11

Convenient route

Question 12

Characteristics of New Drug

Answer 12

1. Drug wherein there’s change in previously approved drug product
2. In combination
3. New use of stablished drug
4. New Dosage regimen sched
5. New route of administration
6. New dosage form

Question 13

Characteristics of Goal Drug

Answer 13

1. Must produce desirable effect
2. least conc. With the least frequency
3. Must have an optimal onset of action and duration of activity
4. Exhibits no side effects
5. Completely eliminated from the body
6. Easily produced at low cost
7. Physically & Chemically stable under storage conditions.

Question 14

Methods of Drug Discovery

Answer 14

Pre Discovery
Target Identification
Target Validation
Drug Discovery
Early safety tests
Lead Optimization
Pre- clinical Studies

Question 15

Understanding the disease

Answer 15

Pre-discovery

Question 16

Choosing of molecule to target with a drug

Answer 16

Target Identification

Question 17

Drug targets

Answer 17

 Receptors – 45%
 Enzymes – 28%
 Hormones – 11%
 Ion Channels – 7%
 DNA–5%
 Nuclear Receptors – 2%
 Unknown – 1%

Question 18

Scientists must understand how:

Answer 18

1. Genes are altered
2. Altered genes affect the proteins they encode
3. Encoded proteins interact with each other in the living cells
4. Affected cells change the specific tissue they are in
5. Disease affect the entire patient

Question 19

Test the target and confirm its role in the disease

Answer 19

Target validation

Question 20

Why is Target Validation Essential in the Drug Development Process?

Answer 20

 Helps scientists avoid research paths that look promising but lead to a dead
end
 Demonstrates that a particular target is relevant to the disease being
studied

Question 21

Find a promising molecule (“lead compound”) that may act on the target and alter the disease course

Answer 21

Drug Discovery

Question 22

Ways in Which Lead Compounds are Discovered

Answer 22

Nature
De novo synthesis
High Throughout Screening
Biotechnology

Question 23

From bacteria in soil or molds in plants, from contents of plants

Answer 23

Nature

Question 24

Molecule or compounds are formed from scratch using computer modeling

Answer 24

De Novo Synthesis

Question 25

The use of automated equipment to rapidly test thousands to
millions of samples for a specific biological target

Answer 25

High Throughput Screening

Question 26

Manipulation, through genetic engineering, of living organisms or their contents to produce drugs

Answer 26

Biotechnology

Question 27

Monoclonal antibody used to treat multiple diseases

Answer 27

Humira

Question 28

insulin used for diabetes

Answer 28

Lantus

Question 29

Example of Antimicrobial

Answer 29

Antibiotic
Antiviral
Antifungal

Question 30

Example of antineoplastic

Answer 30

Anticancer

Question 31

Treatment for breast cancer

Answer 31

Herceptin

Question 32

Lead compounds go through a series of tests to provide an early assessment of the safety of the lead compound

Answer 32

Early safety tests

Question 33

Pharmacokinetic properties of a successful Lead Compound

Answer 33

ADME ( Absorbed, Distributed, Metabolized, Excretion )

Question 34

Lead compounds that pass the initial screening are altered structurally to make them more effective and safer.

Answer 34

Lead optimization

Question 35

Activities involved in lead optimization

Answer 35

1. Biologists test the effect of analogues on biological systems
2. Chemists take this info. to make additional alterations that are retested by the biologists

Question 36

The resulting substance in lead optimization is known as

Answer 36

Candidate Drug

Question 37

Other things to consider in lead optimization

Answer 37

Drug formulation
Delivery mechanism
Large - Scale manufacturing

Question 38

Animal testing

Answer 38

Pre - clinical Studies

Question 39

Comprehensive Drug Abuse Prevention and Control Act of 1970 now referred to as

Answer 39

Controlled Substances Act
[CSA)