Project parameters:
• Name of drug is (Avandia)
Report length – each report should be of a maximum of 3,000 words in length (not including references) written in a suitable font (e.g. Calibri, Arial or Times New Roman) with a minimum size of 11 pt and 1.15 line spacing. Excessive word count may incur a penalty.
Report focus and content ‐ the goal is to describe details of the discovery and development process of the drug with a brief description of the underlying disease state, the class of drug and mechanism of action, its chemical/molecular structure and any specific aspects of the structure that may influence activity (do not cover aspects such as dosage, delivery vehicle or pharmacokinetics unless it is directly related to the topic described next). This should be followed by a particular and detailed focus on identifying any issues or problems during drug development and clinical trials, regulatory approval and/or post marketing surveillances. The review should include any critical data (i.e. tables and/or graphs) and appropriate figures that may illustrate key issues identified. Reference to the intellectual property and its management covering the drug may assist in understanding corporate performance. Attention should be given to the market imperatives and the impact of the circumstances identified. Summarising the lessons learnt through this review of the drug development and marketing would be useful, as would an overall summary. A list of references consulted should be provided at the end in a suitable format (e.g. Chicago, Vancouver), and should include a combination of primary and secondary sources (i.e. research and review articles), government official reports (e.g. FDA, TGA) and other sources (commercial or other organisations), as appropriate.
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