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