Drug development process for Cardiovascular Disease Presentation
TITLE "With the aim of bringing a new drug to market, critically evaluate the drug development Process".
NB The reason for providing you with the above disease is to help structure the actual development process of the drug. In different phases of clinical trials, they may need to go through different regulatory bodies, so it helps to structure the development process of the drug you are going to develop theoretically.
NB: That is not the discovery process. That is just the latest development. So the second half of the drug discovery and development process
The disease or disorder is given above for which they will design a new drug; the new drug is to be theoretical.
The reason for the idea is to take it systematically through the process of development, and you have to continue that through ultimately taking that drug to market.
- Each person should imagine a lead compound has been identified. Begin at the drug development stage where tests on the drug begin in vivo, before ultimately taking it to market.
The presentation must include the following aspects:
- In vivo lead optimization (including animal models and pharmacokinetics)
- How drugs are scaled up the process of that.
- Understand of development process
Process of drug completion
- Background Information on chosen disorder
Introduction and contents
1.Disorder of choice: Overview (background and current knowledge on the disease
- Disorder of choice: Genetic/ protein level information on disorder (genes/ proteins involved and what would be a good target for your new drug)
2.Drug development process
- Critically evaluate the lead optimization stage (include experimental detail) Overview of the
- human clinical trial stages (Phase 1-4)
- Scale up chemistry
- Roles of regulatory bodies (approval and ethics)
3.Conclusion
