Development of medicines

Notes on how drugs are trialled before they are legalised and safe for human consumption. Suitable for OCR B Salters course

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  • Created by: Abigail
  • Created on: 28-02-11 16:36
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The Development of Medicines
Discovery Research
Compound with the desired activity is identified (Lead compound)
Make many close variations (analogues) to try and find a compound with the maximised
beneficial effects (Combinatorial Chemistry)
Development Research
Used to determine whether it is sufficiently stable and how it is likely to be absorbed and excreted
from the body. This involves animal testing to eliminate compounds with undesirable side effects.
Prepare a type of dosage form that is suitable (eg. Injection, inhaler)
Clinical Trials
Phase one ­ First time the drug is given to humans. Usually only healthy volunteers are used. It is used
to determine if the new compound is tolerated and behaves in the way it was predicted to by
experimental investigations. Doses are gradually raised. An application is then made to the Medicines
and Health care Products Regulatory Agency (MHRA) for a certificate to conduct clinical trials. If it is
granted, the drug can enter phase two of clinical trials.
Phase two ­ First in which the illness is treated. Doses given to patient groups.
Phase three ­ Medicine compared to placebo and another medicine currently used for the same
treatment. Doctors and patients do not know what drugs they have been given. Larger samples.
Later Stages of Development
A product license needs to be obtained. Then the drug can be manufactured, marketed and made
available for people to use.

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