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Pharmaceutical Sciences Discussion Paper

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Assignment 2 From Discovery to Production. A specific small molecule drug from the list provided below will be assigned to you. Write a report on its target, how it was discovered and finally scaled-up to make multi kilo quantities. Small Molecule Drugs (Pick one for the assignment – I will announce how each student will be assigned their drug): Vilazodone Atorvastatin Dapagliflozin Levetiracetam Rosuvastatin It can be one that is still in market, or is not in the market and was only used for clinical studies only or a generic or removed from the market and rejected by health authorities. The drug you select should address all the requirements of the assignment. Include the following in the report: 1. Target Section: This section should include the mechanism of action, the target of the drug, details about the disease area. Provide an illustration to support the discussion. 2. Discovery Section: This section should describe how the drug was discovered and details about structure activity relationship studies. Provide illustrations to support your discussion. Then discuss how the drug was synthesized during discovery phase – provide a scheme of the synthesis. (Refer to Lecture 4) 3. Process Development Section: This section should describe how the drug was scaled-up to make multi kilo quantities. Provide a scheme of the process. (Refer to Lecture 5/6). 4. Please pay attention to all the requirements of the assignment. Provide illustrations, schemes and structures where requested. Pay attention that the structures are visible and synthetic conditions are described properly. 5. If the scale-up route or structure activity relationship studies are not available then don’t pick that drug for the assignment. The selection of an appropriate drug that provides all the information required is part of the grade. 6. Provide all references at the end of the assignment. Provide the original reference articles separately. 7. Stick to a 6 page limit. Tips for searching for a drug: Pick a drug that is in the market (can be a generic). Then find the chemical name of that drug – which will be readily available on google. After you know the chemical name you can search for the discovery route, structure activity relationship studies, target of mechanism and process scale-up route using that chemical name. Please provide the references you get all this information from. There can be multiple scale-up routes. It is okay – you just need to pick one. Discovery routes are done on small milligram scale. Process scale-up routes will be done on multi-gram, then multikilo and then multi ton scale. Every time the route could change. You don’t have to provide all scale-up routes. Just one is fine. It also doesn’t have to be the route used for commercial manufacturing either. It could be a scale-up route that was used for Phase 1 or 2 or 3 clinical studies. This assignment is not asking for the formulation or drug product details so please do not provide that. This assignment must be typed and submitted electronically in MS Word (.docx or .pdf) format. The file must be named in the following format: Lastname_Assignment1. Submit your completed document to Assignment 1, listed on the Modules and Assignments pages, as a file attachment. Rubric to be used for grading: Out of 50 points Criteria Drug Selection Target Disease Area Does not meet expectations (0) Does not meet expectations (0) Does not meet expectations (0) Target Mechanism of action Does not meet expectations (0) Discovery Discussion Does not meet expectations (0) Structure activity R-ship Studies Does not meet expectations (0) Discovery Synthesis Process Scale-up Discussion Does not meet expectations (0) Does not meet expectations (0) Process Scale-up route Does not meet expectations (0) Target Discussion Ratings (points) Meets some expectations (2) Meets some expectations (2) Meets some expectations (2.5) Meets some expectations (2.5) Meets some expectations (2.5) Meets some expectations (2.5) Meets some expectations (2) Meets some expectations (3.5) Meets some expectations (3.5) Meets some expectations (2) Meets all expectations (4) Meets all expectations (4) Meets all expectations (5) Points 4 4 5 Meets all expectations (5) 5 Meets all expectations (5) 5 Meets all expectations (5) 5 Meets all expectations (4) Meets all expectations (7) 4 Meets all expectations (7) 7 7 Format, language, Does not meet Meets all 4 adherence to expectations (0) expectations (4) requirements Late penalty: 10% deduction for each day up to 3 days. After 3 days the grade will be 0. Drug Discovery and Early Clinical Development Lopa Bakrania Regulatory Affairs Dr. Lopa Bakrania Pre-Clinical Discovery Phase 1 Phase 2 Phase 3 Launch Commercialization Target Identification Lead Generation Optimization Safety Studies First Human Dose Development Determine safety Establish dose File IND/CTA Side Effects Effectiveness Process Scale-up Robustness Pivotal Trial Validation Edge of failure Design Space Market Approval Patients Continuous Improvement Regulatory Affairs Dr. Lopa Bakrania Drug Discovery Overview Regulatory Affairs Dr. Lopa Bakrania Target Discovery • A target is any system that can potentially be modulated by a molecule to produce a beneficial effect. • A target is a protein molecule although it could be any biological, be it nucleic acid, carbohydrate or lipid etc. • In the past, an animal model of disease could represent a target • Look for proteins or mRNA or genes expressed (or not) in the disease or essential for infectious agent or associated with the disease Regulatory Affairs Dr. Lopa Bakrania Target Validation • Effectively, target validation is a form of risk assessment. The better the validation, the lower the risk in advancing a project. • Hunch
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