pharmaceutical drug development

1. Describe briefly, in an appropriate order, the key stages associated with pharmaceutical drug development for human use (assuming that the product contains a new active pharmaceutical ingredient). Briefly describe the purpose of the stages you have identified.
2. At which point in the development of this drug is the most important patent filed? Briefly explain your answer.
3. What circumstances could prevent a pharmaceutical company from patenting their inventions?
4. A) Therapeutic antibodies can be used to deliver drugs to specific targets by using liposomes – artificial lipid vesicles that contain the drug and have an antibody incorporated at the surface (see attached paper for an example). Outline the key stages in the production of such a product in bulk using a flow diagram and associated text. You will need to consider the production of the antibody (humanised monoclonal antibody) and production of liposomes containing a drug and incorporating an antibody. You do not need to identify specific targets for the antibody/drug, this should be a general outline.
B) Choose two stages in your process that you consider will be crucial in affecting the quality of the final product. Briefly explain the reasons for your choices.
5. Describe briefly how this liposome construct could be developed and tested for human use. In addition to factors specific to your product, briefly describe important general considerations when conducting clinical trials (e.g. adherence to GCP).
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