Drug Development & Testing Flashcards

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1
Q

What is a poison?

A

A relative term relating to the dose necessary to cause harm to an organism

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2
Q

When does a poison become classified as a medicine?

A

If it can kill pathogenic microbes or maligent cancer cells at a dose level which leaves humans alive

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3
Q

What are the characteristics of foxglove leaves?

A

They are poisonous when eaten by humans and other animals. They have a strong bitter taste

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4
Q

What are the symptoms of foxglove poisoning?

A

Dizziness, vomiting, hallucinations and heart failure caused by an irregular heartbeat

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5
Q

What is dropsy now called?

A

Oedema

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6
Q

What is dropsy?

A

It happens when fluid accumulates in the body tissues. This process is painful and can cause a slow death. It is usually caused by heart or kidney problems

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7
Q

Why was William Withering interested in foxgloves?

A

He had heard that it was a cure for dropsy

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8
Q

How many patients did WW study to discover the side effects of digitalis? What did he find?

A

163 patients. He discovered the side effects of digitalis were nauseam vomiting, diarrhoea and green/yellow vision

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9
Q

What did WW find was a sign of recovery?

A

The production of a large quantity of urine

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10
Q

How did he discover the correct dose for his patients?

A

He slowly increased the dose until the patients showed the side effects, he then reduced it very slightly. This was the most effective dose

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11
Q

How did WW communicate his findings to other scientists?

A

He wrote a book about the medicinal properties of the foxglove

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12
Q

What three criteria does a new drug have to satisfy?

A

1) It has to be safe
2) It has to be effective
3) It has to be capable of making a profit

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13
Q

To find a new drug potential substances are?

A

Analysed and the active ingredient is identified and copied so it can be synthetically manufactured

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14
Q

Why are slight variations (analogues) made of the chemical structure?

A

Just in case they might have a better effect

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15
Q

How are most new drugs discovered nowadays?

A

Through computer modelling of their chemical structures

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16
Q

Who are pre-clinical trials carried out on?

A

Animals and isolated cells/tissue cultures

17
Q

What is the purpose of pre-clinical trials?

A

To assess safety and determine whether the compound is effective against the target disease

18
Q

How long do pre-clinical trials usually take?

A

Several years

19
Q

Who are phase 1 clinical trials carried out on?

A

A small group of volunteers, usually healthy

20
Q

What is the purpose of phase 1 clinical trials?

A

To confirm whether or not the drug is being absorbed, distributed, metabolised and excreted by the body in the way predicted by lab tests

21
Q

Who are phase 2 clinical trials carried out on?

A

A small group of around 100-300 of volunteer patients with the disease

22
Q

What is the purpose of phase 2 clinical trials?

A

To look at the drugs effectiveness

23
Q

Who are phase 3 clinical trials carried out on?

A

A large group of around 1000-3000 patients randomly divided into two groups

24
Q

What is the purpose of phase 3 clinical trials?

A

To see if the results will show a statistically significant improvement in patients receiving the drug compared to the placebo

25
Q

What is involved in the testing process for phase 3 clinical trials?

A

One group is given the compound being investigated, the second is given a placebo. It is a double blind trial

26
Q

Who are phase 4 clinical trials carried out on?

A

Everyone who buys the medicine

27
Q

What is the purpose of phase 4 tests

A

To collect data on the effectiveness and safety of the new drug