1.2 Developing Medicines Flashcards

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1
Q

Name the phases of drug discovery

A
Idea/concept phase 
Feasibility 
Target validation
Identification of potential compounds-leads 
Selection of candidate drug
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2
Q

How is HIT identification done?

A

High throughput screening to obtain a starting point

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3
Q

What stage follows on from HIT identification?

A

Lead identification

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4
Q

What processes occur in lead optimisation?

A

Increase potency
Optimise selectivity
Optimise physical properties and Pharmacokinetics
Ensure efficacy in disease models to give confidence for efficacy in man

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5
Q

What are some examples of toxicology tests?

A
Genetic toxicology
Safety pharmacology
General toxicology
Reproductive toxicology 
Carcinogenicity
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6
Q

Describe phase I studies

A

First into man - SAD and MAD
Small number of HEALTHY volunteers
Investigates pharmacokinetics and evaluates safety

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7
Q

What’s the typical volunteer for phase I studies like ?

A

Usually healthy young men
Not taking any medication
Able to give written consent

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8
Q

Name some methods of volunteer recruitment for clinical trials

A

Newspapers
Internet
Radio
Poster displays

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9
Q

What principles underline consent in trials?

A

Use guiding ethical principles
Voluntary
Free to withdraw consent at any time

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10
Q

What 4 things are key to the ethics of clinical trials?

A

Informed consent
Efficient scientific design
Competent authority/legislation
Research ethics committee

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11
Q

What are the four principles of ethics?

A

Justice - being fair
Beneficence - doing good
Non-maleficence - not doing harm
Autonomy - allowing individual to determine what happens to him or her

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12
Q

Describe phase 2 studies

A

Target patient with disease

Involve up to 400 patients

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13
Q

What is a phase IIa study?

A

Pilot study for dose finding

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14
Q

What is a phase IIb study?

A

Measures therapeutic action and determines dose for phase III

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15
Q

Why is a phase II study patient unlike most other patients?

A

They have the disease but don’t have anything else wrong with them

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16
Q

Describe a phase III study

A

Involve patients with a disease
Large multi centre RCT - usually thousands
Last several years
Determines efficacy against standard practice/placebo
Required for regulation and marketing

17
Q

What are phase IV studies?

A

Large scale clinical studies or pharmacovigilance for long term safety
Based on seeking new indications for product
Often outcome based

18
Q

How many volunteers in phase 1 studies?

A

50 healthy volunteers

19
Q

How many volunteers in phase 2 studies

A

200-400 patients with the disease (but no other conditions)

20
Q

How many volunteers in phase 3 studies?

A

1000-3000 patients with the disease

21
Q

How many patients involved in phase 4 studies?

A

<10,000