Assignment help_Module: 321BMS Advanced Pharmacology and Drug Discovery


Faculty of Health and Life Sciences

Module: 321BMS Advanced Pharmacology and Drug Discovery




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Essay = 50% of module mark


 Interpretative essay DUE ON Wednesday 3rd May

Information on this coursework item can be found on pages 1-5 of this document


For this assessment you are required to evaluate, appraise and critique an application for a fictional new drug, based on the clinical trial report submitted to a new medicines regulation agency. Although this is a fictional case study, it is based on the existing clinical trials regulation/drug licensing, the science underlying the drug’s mechanism of action is real, and the task is similar to actual duties conducted by individuals who work in this field.


1) Outline the rationale underlying clinical trial and discuss the potential clinical efficacy of the new drug.

30% of total marks

  1. a) What is problem being addressed (e.g. hypertension) and why are new drugs needed?
  2. b) Describe the proposed mechanism of action of the new drug and how it might produce a therapeutic effect.
  3. c) Discuss the existing available evidence (in real scientific literature) that supports/does not support the likelihood of the new drug being an effective treatment or systemic hypertension.


2) Critique the design and methodology used in the clinical trial to assess the safety and efficacy of the new drug

40% of total marks

  1. a) Describe what flaws exist in the methodology and design of the trial and discuss why they are problematic (in terms of their likely effect on the data and conclusions).
  2. b) Discuss what alternative approaches could have been utilized to improve the reliability/accuracy of the data generated.


3) Discuss and evaluate the conclusions presented in the case study, based on the data presented and the underlying methodology. Make a judgement as to whether there is sufficient available evidence presented in the report to support approving marketing/licensing of the new drug, and justify your decision.

30% of total marks

  1. a) Evaluate the meaning and reliability of the conclusions presented in the report – does the data and methodology support these conclusions?
  2. b) Discuss whether the findings are consistent with the proposed activity of the new drug and previous studies involving drugs with similar pharmacological properties?
  3. c) Does the report include sufficient evidence to support the conclusion that the drug is safe and effective (and therefore approve licensing), and why?



Coursework Instructions and Marking Scheme


As this is an essay type question, you can illustrate your answer using tables, figures, schemes, etc which must each have legends. These will not be counted in the word limit. Please note that only 10% of the world limit will be acceptable. The guidelines below will give you an idea of the different sections that must be included in the report/essay.


Report summary: Begin the report with a brief (150-200 words) overall summary of your evaluation of the new drug, the clinical trial and a concise justification of your decision as to whether to approve or reject the application for licensing.


Structure: Focus on the main questions, tasks and points highlighted in the mark scheme, above, and structure the essay under appropriate headings. Remember that because of the relatively small word limit, you will need to focus on the most important aspects/critiques and only include the most relevant points. A well-structured report would contain the following:


  • A brief, overall summary of the report (discussed above)
  • A section discussing the rationale for the study, the new drug, its pharmacological action, and previous studies relevant to its potential efficacy for treating hypertension.
  • A section evaluating and critiquing the design and methodology of the clinical trial.
  • A section discussing and evaluating the data presented in the report.
  • A concluding section/paragraph in which you state and justify your decision to approve/reject the application for marketing/licensing.


Content: The information used must be relevant and accurate. Every sentence you write must be there for a reason and add quality/value to your report. It is also very important that you fully explain and justify all points that you make. For example, don’t just list things which were bad about the trial’s methodology, ensure that you explain why it is important, what effect it would have, what is the problem with doing it this way, how it should have been done, etc. Also, rather than just stating your opinion, you should construct coherent arguments which are supported by evidence, which demonstrates your point. Overall, the essay must be accurate, relevant, concise and clear. The information presented must be done so in a logical and coherent manner with conclusions fitting what is being discussed.

Where appropriate (e.g. when discussing the drug, its pharmacology and evidence of efficacy contained previous studies), you must research and support your points/argument using Peer-reviewed sources (e.g. articles published in scientific journals). Whenever possible, you should always try to refer to the original research papers that contain the evidence, rather than citing review articles.

Whenever you make an assertion that relies on external facts or evidence, you must support it with references that contain evidence that indicating what you’re saying is true. However when doing so, it is important that you understand, evaluate and synthesise the information, and write it in your own words, rather than simply copying/quoting from the source.


Presentation: You must write using a good standard of written English (grammar, spelling, punctuation, etc.). Appropriate scientific style and terminology should be used. References should be cited and listed appropriately (using CU Harvard styling). Diagrams, figures, tables, etc. can be used to illustrate points, however you must include appropriate figure legends which explain the information contained in the figure table, as well as its relevance to what you are discussing.


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Bad example:

Figure 1: How adrenaline affects airway smooth muscle.


Good example:

Figure 1: The mechanism of action underlying adrenaline’s relaxant effect on airway smooth muscle. To produce its relaxant effects, adrenaline binds to beta-2 adrenergic receptors expressed on airway smooth muscle to trigger a cAMP-dependent signalling cascade. The resulting decrease in airway smooth muscle tone is key to the therapeutic effect of adrenaline in the treatment of asthma.


Also it is much better if you can create your own original diagrams (using PowerPoint, etc.) rather than simply copy/pasting from Google images.


References must also be cited and formatted consistent with CU Harvard guidelines:

Citation (journal article) = (Author et al. 2017)

Reference = Author A, Author B, Author CA, Author D. (2017) Title of paper or study. Journal 66(12):1029-35.


66(12):1029-35= the volume(subsection);start page-end page


You must stay within the word limit. Exceeding the limit by more than 10% will result in marking penalties. Note: the word limit includes all text contained in the report, except for the main title, reference section, and data tables.


Word limit: 1,500 words



Specific help available for the essay

  1. During the module the group will receive guidance in obtaining appropriate information
  2. Students may also use relevant staff’s academic surgeries to discuss specific issues related to the coursework.


Submission date and procedure

Coursework must be submitted online only


An electronic copy only is required. If you hand submit your coursework LATE your overall mark will be penalised in line with standard University Penalties (see below). Electronic copies should be submitted on CU Online, using the TurnItIn link provided by 11.55pm on the due date (see above for due date and requirements).


Normal penalties for late/ none submission apply:

  • work that is submitted late, without an extension or deferral having been granted, will receive a mark of ZERO (students MAY be eligible for a resit attempt)
  • Work that is not submitted will be recorded as ABSENT- students will NOT be entitled to resit the module. THIS MAY HAVE VERY SERIOUS CONSEQUENCES.


If you are unable to hand your coursework in by the required deadline and are eligible for an extension or deferral you must contact the departmental office (JSG23, 02476 88 8175) or your level tutor as soon as possible and BEFORE the date the work is due.



Students are required to sign the declaration on plagiarism on the cover sheet. As stated in this declaration your work must be your own independent piece of work, not produced in collusion with a fellow student (i.e. your work should not be similar to any other students) or plagiarised (copied) from a fellow student or a web site or a text book or any other information source. When referencing sources of information (books, journals or web pages) make sure you use the correct Coventry University Harvard referencing system


Please note that Turnitin will compare your work with material from the Web and from submissions from other students. IT IS VERY IMPORTANT THAT YOU DO NOT COPY AND PASTE MATERIAL FROM THE WEB OR OTHER SOURCES, ALWAYS PUT THE MATERIAL INTO YOUR OWN WORDS.


Penalties for work that is too long

If your work is more than 10% over the word limit then 10% of your mark will be removed as a penalty. Your limit is 1500 words- so you will be penalised if it is more than 1650 words long




  1. Date Handed Out                        

7th March 2017


  1. Date Marked Work will be Returned

Work will be returned within 2 working weeks


  1. Return of Coursework

Work will be returned via the AHO and online via turn it in.


  1. Feedback on Coursework

Written comments will be provided on the scripts and mark sheet


  1. Learning Outcomes: See module guide



HLS Faculty Assessment Marking Criteria (all marks are banded into ONE of 2/3 possible scores per level)




FIRST (Excellent)




The student answers the question fully, particularly in the areas requiring greater analysis, synthesis and evaluation.


  The work is clearly linked and structured, and is also succinct.   A clear and convincing line of argument is presented.   Provides thorough evidential support and critical knowledge of theoretical positions.  




A substantial attempt to answer the question with adequate emphasis on the more analytical components.   Relationships between statements and sections are generally easy to follow, and there is a sound structure.   There is a reasonably clear line of argument.   The need for evidence is clearly recognised, and most claims are supported by relevant evidence.  





Uses some relevant material but not always as effectively as they could be used.   Relationships between statements and sections are sometimes hard to follow or not fully articulated.   The line of argument is not always convincing.   Provision of supporting evidence is spasmodic.  




Does not always answer the question fully.   Relationships between statements and sections are sometimes unclear.   The line of argument is weak in places.   Use of evidence is occasionally weak.  


Compensatory fail: 35,38


Clear fail: 0,10,20,30

Substantially fails to answer the question or to address the topic.   There are few clear links between statements or sections.   Little convincing argument is presented, and is mostly descriptive.   Minimal reference is made to supportive evidence.  


Please note the classification you are given for each of the specified criteria cannot be used to establish the overall mark awarded, it is used as an indication of how your work fulfilled each criterion



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