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Enforcing Financial Reporting Standards: The Case of White ...

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Appendix:<br />

Research Phase &<br />

Safety Pr<strong>of</strong>ile & Efficacy &<br />

Safety &<br />

Pre-Clinical Phase Tests in Everyday<br />

Dosage Range Side Effects Effectiveness<br />

Healthcare<br />

(50 – 100<br />

(100 – 300<br />

(up to several<br />

Environment<br />

volunteers)<br />

patients) thousand patients)<br />

Research Development<br />

5 Million Euros<br />

(2001)<br />

Phase I<br />

10 Million Euros<br />

(2002)<br />

Phase II Phase III<br />

Phase IV<br />

10 Million Euros<br />

(2004)<br />

Authorization by FDA or EMEA<br />

55 Million Euros<br />

(2006)<br />

Payment Structure<br />

Figure 1: Drug Development Process and Payment Structure (Own depiction based on information from FDA).<br />

15

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