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BIMM118<br />

Phase III Studies<br />

• Measurements of adverse effects and possible<br />

benefit made at regular intervals<br />

• Attention to detecting likely occuring side effects<br />

(type A reactions), and unpredictable, rarer<br />

complications (type B reactions)<br />

– Majority of type B reactions may not be seen until post<br />

marketing because during the Phase III trial usually only 2-<br />

3000 people will take the drug, usually for short periods<br />

– Type B reactions typically occur in one in 1000 to 10,000<br />

patients

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