Module 5 Presentations

05/07/2024

Development of GCP Clinical trial (2)

Fifteen hundred years later, the Persian philosopher Avicenna (Ibn Sina)

980–1037 AD wrote about testing of medicines in his multi-volume

“Canon of Medicine” which was a standard medical text in Europe and the

Islamic world until the 18 th century. The Canon of Medicine discussed how to

effectively test new medicines in seven points; for example….

• The effect of the drug must be seen to occur constantly or in many cases, for if this did not happen, it was an accidental effect. • The experimentation must be done with the human body, for testing a drug on a lion or a horse might not prove anything about its effect on man.

The Organisation for Professionals in Regulatory Affairs

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Development of GCP Study design

Cider

Vinegar

Oranges and lemons

12 men with scurvy

Extract with suplhuric acid

• Experiment run by James Lind while serving in the British Navy in 1747 • Those fed citrus fruits experienced a remarkable recovery.

Seawater

Mixture of onion, mustard, horseradish

The Organisation for Professionals in Regulatory Affairs

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