Using the ELISA test as a specific example, discuss the challenges in developing accurate, precise and specific measurements for a biomarker using this technique.

There are several factors that are important to address when critical appraising published scientific literature. Discuss these key factors and provide examples to support your answer.

(40 marks)

Answer 2 questions from the following:

Q2 “The use of animal models is essential in advancing knowledge of human disease.” Discuss this statement providing arguments both for and against using published

literature to support your answer.                                                              (30 marks)

Q3 Discuss the ethical issues around this research proposal:

Professor Thomson is a neurologist specialising in Multiple Sclerosis, with an interest in homoeopathy. He has been asked by a company to trial a new homeopathic drug, aimed at modifying disease related inflammation. It is hoped that the homeopathic therapy would modify an acute inflammatory response in less time and with fewer side effects by comparison to the current therapy. Professor Thomson would like to support the research, however he does not feel he has the time to commit fully, and therefore delegates management of the project to his PhD student. The PhD student designs a single-blinded randomised controlled trial where the neurologist would provide both the homeopathic therapy and current therapy, so that the patients involved would not know which therapy they were receiving. The outcome measures, taken once at the end of

the 6 week period on therapy, involve the assessment of mood, inflammatory markers and satisfaction with the therapy.

(30 marks)


Q4 Using the ELISA test as a specific example, discuss the challenges in developing accurate, precise and specific measurements for a biomarker using this technique.
                                                                                                              (30 marks)


Q5 Discuss the issues in translation of experimental studies in drug research, with reference

to the provision of appropriate dose and dosing regimens in humans. Consider the heterogeneity of the human population in your answer.

(30 marks)

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