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[Ther 201] 1st Exam Transes > Drug Discovery and Development (Raymond V. Oliva, MD) > Flashcards

Drug Discovery and Development (Raymond V. Oliva, MD) Flashcards

1
Q

What was menoxidil originally designed for?

A

Treatment of colds (vasodilator)

However, it was eventually marketed as an anti-hypertensive.

Then, it was marketed to prevent baldness.

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2
Q

T/F: Drugs can target more than one part of the complicated process.

A

False

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3
Q

How long does it take to develop a new drug?

A

10 - 15 years

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4
Q

What is the average cost of drug development?

A

$800 M - $1 B

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5
Q

What do you call herbal products that were dropped from development before being approved?

A

Nutraceuticals

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6
Q

Describe: Pre-discovery phase

A

Understanding the disease and its underlying cause

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7
Q

What is avastin?

A

It’s a chemotherapeutic drug.

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8
Q

Enumerate the ways of finding a new molecule

A
  1. Nature
  2. De Novo
  3. High throughput screening
  4. Biotechnology
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9
Q

How are safety tests conducted?

A
  1. Cells
  2. Animals
  3. Computation Models

These include PCR and HPLC

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10
Q

What are CERA and epoietin beta for?

A

Treating chronic anemia

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11
Q

How would you describe CERA’s binding affinity to its receptor?

A

Lower association

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12
Q

What is lead optimisation?

A

The process of altering lead compounds to make them safer.

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13
Q

What factors are considered in lead optimisation?

A
  1. Formulation
  2. Route of Administration
  3. Large Scale Manufacturing
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14
Q

What are the types of pre-clinical testing?

A
  1. In vitro tests

2. In vivo tests

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15
Q

Why is pre-clinical testing performed?

A

To ensure the drug is safe for humans

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16
Q

How long do pre-clinical tests take on average?

A

1 - 5 years

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17
Q

What is the first step in the drug developmental process?

A

Filing an Investigational New Drug (IND) before testing

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18
Q

All clinical trials must be reviewed by which entity?

A

Investigational Review Board (IRB)

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19
Q

What is the ideal clinical trial for drug testing?

A

Placebo-controlled trial
Randomized
Double-blinded

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20
Q

What question is asked in Phase 1?

A

Is the treatment safe?

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21
Q

What is the sample size for Phase 1?

A

N = 20 - 100

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22
Q

Who are the subjects in a Phase 1 trial?

A

Healthy individuals

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23
Q

What is the purpose of a Phase 1 trial?

A

Determine the safe dosing range

24
Q

How long does a Phase 1 trial usually take?

A

6 - 9 months

25
Q

What is the question asked in Phase 2?

A

Does the treatment work?

26
Q

Who are the subjects in a Phase 2 trial?

A

Diseased patients

27
Q

What is the sample size for a Phase 2 trial?

A

N = 100 - 500

28
Q

How long does a Phase 2 trial usually take?

A

6 months - 3 years

29
Q

What can you say about the doses included in a Phase 2 trial?

A

Presence of low and high dose and negative control

It is concerned with the maximum therapeutic threshold.

30
Q

Phase IIA studies are also known as?

A

Proof of concept studies

31
Q

T/F: Phase IIA studies are well controlled clinical trials conducted to evaluate safety and efficacy in selected populations of patients.

A

False

They are pilot clinical trials.

32
Q

What do objectives of Phase IIA studies focus on?

A

Dose-response
Type of patient
Dosing frequency

33
Q

What phase of clinical trials represents the most rigorous demonstration of a medicine’s efficacy?

A

Phase IIB

34
Q

T/F: Phase IIB studies are sometimes referred to as pivotal studies.

A

True

35
Q

What are the questions asked in Phase III?

A

Will the treatment prolong life?

Does the new treatment work better than the standard treatment?

36
Q

What experimental design does Phase III utilise?

A

Randomized controlled trial (RCT)

37
Q

What is the sample size for Phase III studies?

A

N = 1000 - 5000 (except for cancer studies)

38
Q

What is the objective of a Phase III study?

A

To generate significant data on efficacy, safety and overall benefit-risk of the drug

39
Q

How long does a Phase III study usually take?

A

1 - 4 years of testing

40
Q

The Philippines is involved in several Phase III studies for what types of drugs?

A

Anti-hypertensive

Anti-diabetic

41
Q

Phase IIIA trials are conducted prior to submission of what to the FDA?

A

New Drug Application (NDA)

42
Q

Phase IIIA clinical trials are conducted in what kind of population?

A

The population for which the medicine is intended

43
Q

Trials of which phase provide much of the information contained in the package insert?

A

Phase IIIA

44
Q

T/F: Clinical trials for special groups or under special conditions are also conducted in Phase IIIA

A

True

45
Q

Can placebos be used on anti-asthmatic drugs?

A

No, but they can be used for drugs for diabetes mellitus

46
Q

When does Phase IIIb occur?

A

After submission of the NDA but prior to medicine’s approval and launch

47
Q

Describe the nature of Phase IIIb trials

A

Supplement earlier trials
Complete earlier trials
Directed towards new types of trials or Phase IV evaluation

48
Q

With regards to manufacturing, a company must meet the FDA guidelines for what?

A

Good Manufacturing Practices (GMP)

49
Q

What is the question asked in Phase IV studies?

A

Is the treatment safe over time?

50
Q

What is the only approved COX-2 inhibitor in the US?

A

Celebrex

51
Q

What COX-2 inhibitor marketed by Merck & Co. was withdrawn from the market for allegedly causing CVDs?

A

Viox (Rofecoxib)

52
Q

What anti-diabetic drug marketed by GlaxoSmithKline was withdrawn from the market for allegedly causing heart failure and stroke?

A

Avandia (Rosiglitazone)

53
Q

T/F: A drug in Phase III trial cannot be given to pregnant women, children, insulin-dependent patients and patients with New York Heart Failure Classification 3 and 4

A

True

54
Q

How long do the drug discovery and pre-clinical stages take on average?

A

3 - 6 years collectively

55
Q

How long do Phases I - III of clinical trials take?

A

6 - 7 years collectively

56
Q

How long does an FDA review of a drug take?

A

0.5 - 2 years

[Ther 201] 1st Exam Transes (11 decks)

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