Drug Discovery

Question 1

What is aetiology?

Answer 1

the cause, set of causes, or manner of causation of a disease or condition

Question 2

What is a drug?

Answer 2

an agent used in diagnosis, treatment, cure, or prevention of disease

Question 3

What happens if a drug is given to a healthy individual?

Answer 3

it is considered a poison, it skews the biological system

Question 4

What is a lead compound?

Answer 4

a chemical compound with desired biological or pharmacological activity, it shows promise of treatment

Question 5

What is a prodrug?

Answer 5

a compound that requires metabolic biotransformation after administration to be active

Question 6

What are a few reasons for using a prodrug?

Answer 6

controlled release
targeting
stability
better distribution
shelf-life

Question 7

What is a dosage form?

Answer 7

the types of preparation in which the drug is presented to the patient (active+inactive ingredients, tablet, capsule, syrup, etc.)

Question 8

What is the rationale of dosage form?

Answer 8

safe and convenient ways of administering an accurate dose, protect the drug against decomposition, taste, controlled release

Question 9

Differ proprietary name from non-proprietary name. Which is first in the drug discovery process?

Answer 9

Propietary name (brand name) can only be used by the inventor, any other companies must use the non-proprietary name (generic)
non-proprietary name comes first in the drug discovery process

Question 10

What is pharmaceutics?

Answer 10

the science of drug formulation

Question 11

What is biopharmaceutics?

Answer 11

the study of the properties of the drug and dosage form after administration

Question 12

What is pharmacokinetics?

Answer 12

what the body does to the drug (ADME)

Question 13

What is pharmacodynamics?

Answer 13

what the drug does to the body

Question 14

What is a new drug?

Answer 14

a new chemical entity or a modification to an old drug
any drug that has not been generally recognized as safe and effective yet

Question 15

Typically how long is the drug discovery process?

Answer 15

10-12 years

Question 16

What is the order of the drug discovery process?

Answer 16

drug discovery–>pre-clinical trials–>clinical trials–>FDA review–>MFG–>post-marketing surveillance

Question 17

true or false: the drug discovery and pre-clinical stage generally occur in vitro

Answer 17

true

Question 18

At what stage do dosage forms tend to occur?

Answer 18

pre-clinical

Question 19

At what stage does a company file a patent for a new drug?

Answer 19

pre-clinical

Question 20

How many phases are there during the clinical trials? What general happens in each phase?

Answer 20

phase 1: healthy individuals, safety, PK
phase 2: individuals with the disease, efficacy, dosing
phase 3: safe and effective for a wide variety of people

Question 21

What is IND? When is it submitted?

Answer 21

investigational new drug (a request from the sponsor to administer an investigational drug)
submitted after pre-clinical trials

Question 22

What is NDA? When is it submitted?

Answer 22

new drug application (sponsor believes enough evidence has been gathered to meet FDA requirements)
submitted after phase 3 of clinical trials

Question 23

What is the Special Access Programme?

Answer 23

an emergency release, a physician requests a developing drug for a patient whos condition is worsening

Question 24

Is the patient part of the clinical trials when obtaining a drug through SAP?

Answer 24

no

Question 25

Why do traditional drugs take 18 months for approval and biological drugs take 25 months?

Answer 25

the complexity, it is difficult to find a panel of experts

Question 26

What is the Fast Track Program for approval?

Answer 26

more money is put into the project to speed up development, usually for life-threatening illness

Question 27

What is the biggest interest of a drug inventor?

Answer 27

producing line extensions

Question 28

True or false: a drug can be removed from market

Answer 28

fact stuff that did not appear in clinical trials can appear post-marketing

Question 29

What is CADTH and what do they do?

Answer 29

Canadian Agency for Drugs and Technologies in Health they make economical decisions to suggest to provinces which drugs should be in the formulary

Question 30

What does PMPRB do?

Answer 30

agency reviewing prices of drugs

Question 31

What are we watching for in postmarketing? What is the inventor hoping to gain during postmarketing?

Answer 31

adverse reaction reports and defects the inventor is hoping to put out line extensions

Question 32

What is a patent?

Answer 32

gives the inventor the right to prevent others from making, selling, or importing a product based on the patented invention without permission

Question 33

What are some patent protection strategies?

Answer 33

new clinically superior formulas new routes of administration new uses chiral switches applying more than one strategy at the same time

Question 34

True or false: the brand name is patent protected

Answer 34

true

Question 35

What are some characteristics of generic products?

Answer 35

copy of the brand name same active ingredients same strength, dosage form, administration route bioequivalent to the brand name LOWER COST

Question 36

True or false: two "identical products" may vary in clinical effectiveness

Answer 36

true

Question 37

How is bioequivalence testing done?

Answer 37

lab testing (dissolution) cross over study

Question 38

Explain the difference between a drug and drug product.

Answer 38

a drug is the active ingredient, the drug product is the finished product (active ingredient, non-medicinal additives, dosage form, preparation method)

Question 39

What is pharmaceutics concerned with?

Answer 39

formulation manufacturing stability effectiveness

Question 40

What is a superior formulation?

Answer 40

anything that changes efficacy and safety ex: changing frequency from once a day to once a week

Question 41

Which company has the right to making modifications to an existing drug?

Answer 41

the patent company

Question 42

Can a specific patent be extended?

Answer 42

no you must create something new to receive a patent

Question 43

What is the name of the application you make if you are filing to create a generic product? What is its goal?

Answer 43

Abbreviated New Drug Application (ANDA) the goal is to test the similarities between the generic and brand name

Question 44

Why do we perform bioequivalence tests?

Answer 44

to ensure the generic product is equal to the brand name in safety and efficacy

Question 45

Do we perform patient testing with generic products?

Answer 45

no we test bioequivalence in a healthy individual

Question 46

Why are generic products sold at a substantial discount compared to the brand name?

Answer 46

they did not have to undergo costly preclinical and clinical trials