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This capstone unit develops the critical thinking needed to transform a new therapeutic drug or a device into a commercially viable product. Students will critically appraise scientific and clinical data and information in order to prepare sections of the final scientific dossier that would be suitable for submission to the TGA, EMA or FDA. Students will determine the submission strategy and solve clinical/scientific issues related to core aspects of the process (i.e. chemistry, manufacturing, quality, stability, safety, clinical trial or other suitable component of the process).
Study level | Postgraduate |
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Academic unit | Pharmacy |
Credit points | 6 |
Prerequisites:
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None |
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Corequisites:
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CEPI5100 and 18 credit points of stream specific units of study from any of (PCOL5101, PCOL5102, PCOL5103, PCOL5105, PHAR7815) |
Prohibitions:
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None |
Assumed knowledge:
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None |
At the completion of this unit, you should be able to:
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