Pick ONE of the five drug products listed and summarize in a presentation how you would write an IND application for the product. Be aware that this is not a full IND application but rather an outline. Consider that all of these products are of compounds that have been approved by the FDA before, so the formulation is actually the new part. Nonetheless, you will have to demonstrate the various properties of the compound itself. This requires extensive literature research – so definitely get started early on this assignment. All the tools to complete the assignment are available to you – you know how to find information on the mechanism of action for a drug, how it may interact with a target, what assays can confirm target interactions, metabolic routes, permeability, etc.
Also address safety and efficacy for your product and how the initial phase 1 study will be conducted to establish the first-in-human trial for later dosing. Again, consider that all of the drugs were previously approved by the FDA, so you will find information in the literature about them.
Your presentation should at least include an introduction, conclusion, and reference slide and a total of 10-12 slides (although there can be more). The length of the presentation is not limited but should be no shorter than 15 minutes. It needs to be narrated (your own voice) using VoiceThread.
Final assignment: the last assignment for this course is a comprehensive presentation on the content of an IND submission for a drug product. Use the IND application submission checklist [ Investigator’s Checklist508Compliant 9-23-2013-1.PDF
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] to create a Powerpoint presentation and summarize what information needs to be contained in each part of the application after picking one of the drug products from the list below. You can use any and all information provided in the modules and courses you have studied so far. Make sure to cover the following information:
Physicochemical properties of the drug
Pharmacokinetics
Pharmacodynamics & mechanism of action
Toxicity, expected adverse effects
Safety & risk management
Dosing regimen in phase 1 clinical study
Initial labeling of drug product
Your presentation cannot contain animations, needs to be uploaded to VoiceThread, narrated, and should be between 15-20 minutes long (approximately 10-12 slides). It should contain one cover, introductory, and reference slide. There is no penalty for longer duration of the recording or more slides, only for too brief presentations that do not provide sufficient information on the chosen drug and the IND application.
Drug products to choose from:
Acetylsalicylic acid enteric-coated tablet for oral administration
Cefazolin sodium powder for intravenous administration
Erythromycin ethylsuccinate suspension for oral administration
Theophylline anhydrous extended release tablets for oral administration
Levalbuterol tartrate solution for inhalation
