Compare Historic Drug Testing With Contemporary Drug Testing

7/28/2019 Compare Historic Drug Testing With Contemporary Drug Testing

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The extract from the foxglove plant which is used totreat patients with heart disease is known as digitalis

which was found by William Withering.

He bought the recipe for a herbal cure for oedema

from a patient.

This medicine was a mixture of several herbs and

that include Digitalis.


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He began with a low dose of his owndigitalis soup and increased it until thepatient suffered side effects. He used low levels of this soup where noside effects develop. This was considered as the ideal dosage. This extract is digitalin and is used to treatheart disease.It is ethically wrong as the over dose is fatal


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In double blind trial neither the participants northe researchers know which participants belong tothe control group and who is being treated.

This method can be applied to any experimentalsituation where there is a possibility that theresult will be affected by bias.

If the treated group shows significantly betterresults than the placebo control group, then thetreatment has passed the trial.


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Medically ineffectual treatment for adisease intended to deceive the patient.

In a common placebo procedure a patient isgiven an inert pill told that it may improve

his/her condition.

But not told that it is in fact inert.


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This may cause the patient to believe that thetreatment will change his/ her condition.

They may feel that their condition has improved

or there is an actual improvement .

This phenomenon is called placebo effect

Loss of trust between the patient and the doctor


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Every medicine that comes into themarket today is the result of years ofresearch and development. It takes around 10 years to develop anew drug.


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A new medicine has to be: Effective-it cures or prevents the disease itis designed for. Safe- non toxic and without unacceptableside effects. Stable-able to be stored under normalconditions Easily taken into and removed from thebody- able to get into the target. Capable of being made on a large scale-

able to be manufactured in large quantities.


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Pre-clinical testing-the proposed drug is firsttested on cell cultures, tissue cultures and wholeorgans in the lab.

To see if the compound does what the scientist

thought it would. Phase 1-A small group of healthy volunteers (20-100)is

given the drug to see1. if it is safe2. how quickly it is absorbed, metabolized and

excreted from the body


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Phase 2-A group of volunteers with disease are giventhe drug to see1.how effective it is against the signs andsymptoms of the disease.2. what doses are the best.3. what are the side effects.

A control group is given dummy dose(placebo)


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Phase 3-Hundreds to thousands of patients are giventhe drug to get more reliable data on its1. effectiveness2.safety3. best dose4. rare side effects

If all goes well it is put forward to licensingauthority


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Safer: Use of specific active ingredient should allow a more

precise dose to be given. Any serious ill effects may be detected in the animal

trials first More reliable: Uses larger samples reduces effects of chance/random

variation Double blind testing avoids patient/researcher bias in

observing, recording and interpreting effects Statistical analysis of data improves accuracy of

conclusions as to whether or not drug actually doeshave an effect or not.


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Similarity

Groups of patients undergoing treatmentvary from small to large group.

A potentially useful medicine is identified.


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William Withering Contemporary threephase trial

No trials on healthy people Trial first carry out on healthy

people

No test on laboratory animals Test on laboratory animals

Approval and licensing notrequired

Approval and licensing required

Documents

Compare Historic Drug Testing With Contemporary Drug Testing