Learning objectives
To provide the goals and the "in vitro" and "in vivo" methods for the preclinical studies of biotechnological drugs.
Prerequisites
None.
Course unit content
<ul>
<li>Legal aspects regulating the preclinical studies on biotechnological drugs </li>
<li>Studies assessing the quality of drugs </li>
<li>Studies assessing the biological activity of drugs </li>
<li>Studies assessing pharmacodynamics of drugs </li>
<li>Studies assessing pharmacokinetics of drugs <br />
</li>
</ul>
Full programme
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Bibliography
<ul>
<li>Walsh G "Biopharmaceutical: Biochemistry and Biotenchology" Wiley (1998) <br />
</li>
<li>Crommelin DJA, Sindelar RD "Pharmaceutical Biotechnology" Harwood Academic Publishers (1997) <br />
</li>
</ul>
Teaching methods
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Assessment methods and criteria
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Other information
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