This diploma thesis focuses on drug approval efficiency. It is obvious that the drug approval process is lengthy and expensive. The question that arises is whether the length of the drug approval process, as well as associated costs, leads to better safety. The first part briefly summarizes the history of the drug regulation and the drug legislative in the Czech Republic. Also focuses on the theory of economic regulation and the theory of bureaucracy. The second part deals with the drug approval process for new drugs, describes preclinical and clinical testing in relation to the analysis of Sam Peltzman. The third part compares drug approval process in different markets. The last part summarizes off-label prescribing, especially in pediatric.
| Identifer | oai:union.ndltd.org:nusl.cz/oai:invenio.nusl.cz:10818 |
| Date | January 2009 |
| Creators | Hlaváčová, Markéta |
| Contributors | Šíma, Josef, Ždímal, Martin |
| Publisher | Vysoká škola ekonomická v Praze |
| Source Sets | Czech ETDs |
| Language | Czech |
| Detected Language | English |
| Type | info:eu-repo/semantics/masterThesis |
| Rights | info:eu-repo/semantics/restrictedAccess |
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