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PHAR122 > Drug Discovery > Flashcards

Drug Discovery Flashcards

1
Q

What is aetiology?

A

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

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2
Q

What is a drug?

A

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

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3
Q

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

A

it is considered a poison, it skews the biological system

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4
Q

What is a lead compound?

A

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

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5
Q

What is a prodrug?

A

a compound that requires metabolic biotransformation after administration to be active

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6
Q

What are a few reasons for using a prodrug?

A

controlled release
targeting
stability
better distribution
shelf-life

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7
Q

What is a dosage form?

A

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

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8
Q

What is the rationale of dosage form?

A

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

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9
Q

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

A

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

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10
Q

What is pharmaceutics?

A

the science of drug formulation

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11
Q

What is biopharmaceutics?

A

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

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12
Q

What is pharmacokinetics?

A

what the body does to the drug (ADME)

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13
Q

What is pharmacodynamics?

A

what the drug does to the body

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14
Q

What is a new drug?

A

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

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15
Q

Typically how long is the drug discovery process?

A

10-12 years

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16
Q

What is the order of the drug discovery process?

A

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

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17
Q

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

A

true

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18
Q

At what stage do dosage forms tend to occur?

A

pre-clinical

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19
Q

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

A

pre-clinical

20
Q

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

A

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

21
Q

What is IND? When is it submitted?

A

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

22
Q

What is NDA? When is it submitted?

A

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

23
Q

What is the Special Access Programme?

A

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

24
Q

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

A

no

25
Q

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

A

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

26
Q

What is the Fast Track Program for approval?

A

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

27
Q

What is the biggest interest of a drug inventor?

A

producing line extensions

28
Q

True or false: a drug can be removed from market

A

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

29
Q

What is CADTH and what do they do?

A

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

30
Q

What does PMPRB do?

A

agency reviewing prices of drugs

31
Q

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

A

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

32
Q

What is a patent?

A

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

33
Q

What are some patent protection strategies?

A

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

34
Q

True or false: the brand name is patent protected

A

true

35
Q

What are some characteristics of generic products?

A

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

36
Q

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

A

true

37
Q

How is bioequivalence testing done?

A

lab testing (dissolution)
cross over study

38
Q

Explain the difference between a drug and drug product.

A

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

39
Q

What is pharmaceutics concerned with?

A

formulation
manufacturing
stability
effectiveness

40
Q

What is a superior formulation?

A

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

41
Q

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

A

the patent company

42
Q

Can a specific patent be extended?

A

no
you must create something new to receive a patent

43
Q

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

A

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

44
Q

Why do we perform bioequivalence tests?

A

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

45
Q

Do we perform patient testing with generic products?

A

no
we test bioequivalence in a healthy individual

46
Q

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

A

they did not have to undergo costly preclinical and clinical trials

PHAR122 (1 decks)

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