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SCIE50028 CASE STUDY #2
Please read the following case study (and questions) carefully. Identify the key words in the case study
and perform a literature review using these key words. As part of your response, please provide a
reference list with the references you identified from your literature search (in APA format).
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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