Introduction ~200 words (10/70) What is the drug? What is the disease(s) that it treats? –> Focused on the first discovery How is the drug used? How effective /successful is the drug? Historical details of when the drug first approved, its current status (is it still leading treatment)? Target directed drug discovery ~650 words (30/70) What is the therapeutic pharmacological target(s) that this drug binds to? – Focus on initially identified target – Mention if the drug has another receptor (with few sentence) How was this target identified as being promising for the treatment of the disease? – If a receptor or enzyme, where is it expressed??o What are the intracellular signalling cascades / genes / reactions it controls? – Its role in physiology, behaviour? Interaction with the disease? – What happens if you genetically knock it out? Use pharmacological agents (i.e. initial agonist/antagonists, monoclonal antibodies, etc)? What is the link or relevance of these endogenous properties with known disease pathways? – Most of this research was probably conducted within the public sector, and may have been completed before or after the target was identified lots of overlap between these two. How was the lead compound (that was used for subsequent drug development) discovered or generated? – Was it a compound that was already being used by public research groups? Was it discovered by a big pharmaceutical company? – Did they screen the pharmacological target against their library of compounds, to derive some potential lead compounds? Did they chemically alter an existing drug? – Was any research or screening performed (cell, tissue, animal-based?) to select the best lead compound (i.e. with the best pharmacological properties, efficacy in mouse models, etc) from a group of potential lead compounds? Drug development ~450 (20/70) – Pharmaceutical development ? the process of forming an appropriate dosage form (eg. Tablet , cream ) – Pre-clinical development ? toxicology/ safety screening in animal and analysis of pgarmacokinetics – Clinical development ? 1. Phase 1.11a, 11b and 111 trials, which prove the safety and effectiveness of the treatment 2. How were these conducted ( what patients were recruited etc) and what did they show? – Commercialisation / successful therapeutic treatment 1. What form did the final market- place product take? 2. Were there key features and benefits of this drug that made it better than existing alternatives? 3. How was the drug marketed in various countries? (both to the public, and to health practitioners?) 4. $ Price? Government subsidised? Conclusion ~200 (10/70) Summaries
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