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Dictionary of Evidence-based Medicine.pdf

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<strong>Dictionary</strong> <strong>of</strong> <strong>Evidence</strong>-<strong>based</strong> <strong>Medicine</strong> 49<br />

Year Stage Activity<br />

1<br />

2<br />

3<br />

Activity<br />

screening<br />

High throughput screening<br />

Enzyme system: receptor binding; reporter gene<br />

Rational drug design<br />

4<br />

5<br />

6<br />

Pre-clinical<br />

testing<br />

Animal toxicity testing<br />

7<br />

8<br />

Phase I<br />

studies<br />

Human studies in healthy volunteers (-100 subjects)<br />

Identification <strong>of</strong> obvious toxicity and safety problems<br />

Pharmacological pr<strong>of</strong>iling<br />

9<br />

10<br />

11<br />

Phase II<br />

studies<br />

Human studies in patients (-500 subjects)<br />

Pilot efficacy studies<br />

Dose-finding studies<br />

12<br />

13<br />

Phase III<br />

studies<br />

Human studies in patients (-2000 patients)<br />

Pivotal efficacy studies<br />

14<br />

Drug<br />

registration<br />

Drug licence application<br />

14<br />

Product<br />

launch<br />

Drug marketing<br />

14<br />

Phase IV<br />

studies<br />

Post-marketing surveillance<br />

Yellow card scheme<br />

Formal studies<br />

14+<br />

Post-marketing<br />

development<br />

New formulations<br />

Trials for new indications<br />

20+<br />

Downregulation<br />

Application to make products available<br />

for self-medication<br />

Figure 6 Drug development

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