After you identify your reference list, use these references to answer the case study question listed below.
After you identify your reference list, use these references to answer the case study question listed below. You will need to submit your responses to this case study along with your reference sheet for grading. Case Study: You are working in a pharmaceutical company that is developing a monoclonal antibody treatment for a specific condition. Preclinical development has been completed (using cell cultures and two animal models) and the company is now ready to enter human testing (clinical research) for this monoclonal antibody treatment. 1. Provide a brief description of the activities that the company will have done for their preclinical development (your summary should be half a page as a maximum) 2. Which animal models would most likely be used to develop a monoclonal antibody? Please provide a pharmacological justification for the use of these species of animals 3. To perform clinical research using humans, the pharmaceutical company will need to determine an appropriate dose to administer to humans (based on their pre-clinical data and results). Provide two parameters that can be used to “extrapolate” a human dose (based on animal doses) and select the most appropriate one to use. Please provide your answer in a maximum of two pages (single or double spaced with normal margins). The references should be part of this two-page limit. The idea is not to provide a detailed response to this case study; you do need to identify the key words though required to formulate a response and address these key words / ideas. This is an individual assignment and all your submissions will be verified for authenticity and originality using TurnItIn® (through SLATE). Please refer to the rubric for a guideline on how this assignment will be graded.
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