Dictionary of Evidence-based Medicine.pdf
Dictionary of Evidence-based Medicine.pdf
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