Treatment should be addressed for a heart and vascular system disease. Individua


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Treatment should be addressed for a heart and vascular system disease.
Individual Project
Your research team has identified a therapeutic lead compound for the treatment of disease. You are now in a position to write a proposal to develop and test your lead therapeutic. The goal is to accelerate the translation of your basic research discoveries into therapeutic candidates for clinical testing in humans.
Write a proposal for preclinical testing outlining an appropriate milestone plan. Your proposal must include experiments for the analysis of pharmacokinetics and toxicological testing of your compound (including in vitro and in vivo tests). The plan must be based on a clearly stated timeline that includes defined interim goals.
General Proposal Structure
Abstract (max 100 words)
This should be a short summary of the proposed work.
Introduction (max 1,250 words)
The Introduction begins
My research team has identified a candidate therapeutic drug. Here I submit a proposal for preclinical testing: specifically to determine the pharmacokinetic and toxicological properties of our candidate therapeutic……….
The introduction should address the following points
What is preclinical testing and why is it important?
How relevant is preclinical testing to predicting drug efficacy and safety in humans?
o Discuss how the application of novel organ-on–chip technologies might improve preclinical predictions of human drug responses.
o Is animal research necessary, and if so how can it be best managed?
Remember: Figures can be useful to help illustrate a point.
Aims (max 1,250 words)
Milestones should be constructed to include
-the goals and a timeline (months/years) for completion
-pharmacokinetic (ADME testing) & toxicology testing- what are the types of tests you propose?
o use of cell culture
o use of organ-on-chip technology to more reliably predict the efficacy, toxicity and
pharmacokinetics of you lead compound o use of animals
-the criteria to measure success of your tests
e.g. Toxicology studies will be performed in X number of species for X number of days and the required outcome would be to observe no adverse effects at drug levels X-fold above a proposed therapeutic dose.
References
Cite all references used in preparing you proposal; this includes books, journals, and websites.

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