Method Development And Validation, Quality Based Design For Cyclophosphamide Using Hplc

School of Pharmacy and Biomedical Science

UCLan Coursework Assessment Brief Academic Year 2020/21

Module Title: Quality Assurance, Clinical Trials and Regulatory Affairs Module Code: PJ4018

Level 7

Paper critique presentation (assessing PAT, QbD, analytics for quality)

This assessment is worth 30% of the overall module mark

 

INSTRUCTIONS

You are to provide a critical evaluation of two research articles related to Process Analytical Technology (PAT), Quality by Design (QbD) and/or analytics of quality in pharmaceutical industry, and present a paper critique assessing the chosen articles as an oral presentation, which would be followed by questions (20 minutes in total).

.

You should plan carefully the structure and content of the presentation before writing. Although there is no limit to the number of slides or diagrams to be presented, you are strongly recommended to practise your presentation to fit within a 15-minute time frame.

 

The presentation must demonstrate your own critical analysis on the appropriate research papers selected. It is important that you present your information appropriately and clearly to support your discussion on the chosen topic.

You should include the following in your presentation:

• Background information of your chosen topic

• The reasons for selecting the two journal articles for discussion

• Critical evaluation of the selected journal articles, in terms of the analytical methods used (and alternatives that could be used), results and conclusion

• Complete bibliographical details in Harvard format

Learning outcomes for this module:

The highlighted learning outcomes would be assessed, and this assignment accounts for 30

% of the total module mark

1. Select and articulate the relevant regulatory aspects of drug development.

2. Source and interpret current regulatory documentation and guidelines.

 

3. Critically evaluate the principles and applications of selected analytical techniques

used in pharmaceutical analysis and propose appropriate techniques in practice.

 

4.

Analyse a range of data and information derived either experimentally or from within

scientific literature/data banks and evaluate it, critically supported by logical and

structured arguments.

 

5. Integrate advanced skills in self-management, personal development, initiative

and critical autonomy in addressing and finding solutions to research based

problems.

 

 

 

 

PREPARATION FOR THE ASSESSMENT

You would need to consider the following;

• What is the main theme of your discussion?

• What are the aims / objectives of the presentation? What is the ‘research question’ of the presentation?

• How do you think you could present your argument clearly and precisely? What information is needed to support your discussion?

• What information is necessary e.g. what information should be provided to help the audience understand the chosen topic? How do you construct your argument clearly? What is the take-home message? How should the presentation be laid out? What is the sequence / order of the slides, colour themes etc. You are advised to get the contents sorted out before spending time on sophisticated usage of graphics.

• References to be used for the presentation

 

You should use your lecture / workshop notes as well as the recommended textbooks and

journal articles on the pre-clinical and clinical trials, regulatory affairs and stability testing

and other relevant required texts to help you build your report. Please note that you may

need to refer to your learning in the PJ4012-dug development and discovery module!

 

You are also strongly recommended to start preparing early for this before the deadline!

 

The reading list can be accessed on

https://uclan.alma.exlibrisgroup.com/leganto/readinglist/searchlists/4476121940003821

RELEASE DATES AND HAND IN DEADLINE

 

Assessment Release date: [18th January 2021]

 

Assessment Deadline Date and time: [The deadline for submission is Sunday 11th April, 2021

at 11:59 pm]

 

Please note that this is the final time you can submit – not the time to submit!

 

 

SUBMISSION DETAILS

 

You will also need to submit the final presentation slides by Sunday 11th April 2021 via Turnitin (in ppt or pptx format). The presentation would be held in the week commencing 12th April. Refer to your online timetable for details The presentation should be produced using suitable presentation software (e.g. powerpoint). Any diagrams, chemical structures and equations should be illustrated using appropriate software packages that are compatible with the presentation software used.

We expect you to develop the skill of getting a point across concisely and remove unnecessary text. Therefore, you must ensure that your presentation can be properly delivered within 15 minutes.

 

 

 

HELP AND SUPPORT

 

• Questions arising from this assessment brief and academic support would be handled by

1. Emailing Dr Enoche Oga (EOga@uclan.ac.uk)

2. Discussing with the relevant tutor

3. Discussed during teaching sessions

 

• For support with using library resources, please contact Louise Smith

(LSmith53@uclan.ac.uk). You will find links to lots of useful resources in the My Library

tab on Blackboard.

• If you have not yet made the university aware of any disability, specific learning difficulty,

long-term health or mental health condition, please complete a Disclosure Form. The

Inclusive Support team will then contact to discuss reasonable adjustments and support

relating to any disability. For more information, visit the Inclusive Support site.

• To access mental health and wellbeing support, please complete our online referral form.

Alternatively, you can email wellbeing@uclan.ac.uk, call 01772 893020 or visit our UCLan

Wellbeing Service pages for more information.

• If you have any other query or require further support you can contact The <i>, The

Student Information and Support Centre. Speak with us for advice on accessing all the

University services as well as the Library services. Whatever your query, our expert staff

will be able to help and support you. For more information , how to contact us and our

opening hours visit Student Information and Support Centre.

• If you have any valid mitigating circumstances that mean you cannot meet an assessment

submission deadline and you wish to request an extension, you will need to apply online

prior to the deadline.

 

 

If you have any questions about this assignment, please contact Dr Enoche Oga

 

Disclaimer: The information provided in this assessment brief is correct at time of

publication. In the unlikely event that any changes are deemed necessary, they

will be communicated clearly via e-mail and a new version of this assessment

brief will be circulated.

Version: 1

 

 

87, 94, 100 74, 80 62, 65, 68 52, 55, 58 ≤50% (Minimum pass & Fail

Knowledge and comprehension (e.g. understand a paper critique that assesses PAT, QbD, analytics for quality) (20% weighting)

Excellent breadth and depth of relevant knowledge and excellent use and integration of high-quality sources, with evidence of reflection/demonstration of clear understanding of the literature. Evidence of substantial independent acquisition of knowledge and concepts. Excellent exposition of concepts/theory material.

Substantial breadth and depth of relevant knowledge and use of high- quality sources that demonstrates understanding of the literature. Evidence of significant independent acquisition of knowledge and concepts. Good exposition of concepts/theory material.

Adequate breadth and depth of relevant knowledge and use of relevant sources. Some evidence of independent acquisition of knowledge. Good exposition of concepts/theory material.

Limited breadth and depth of relevant knowledge and use of relevant sources. Limited evidence of independent acquisition of knowledge. Some limitations apparent in the understanding of concepts/ theory.

Lacks breadth and depth of relevant knowledge. Basic restatement of a limited range of material. Very little or no evidence of independent acquisition of knowledge. Limited understanding of subject / topic / concept / theory

 

 

Application (e.g. potential opportunities and challenges for the pharmaceutical industry) (20% weighting)

Originality in the application of knowledge, together with the successful application of established techniques of research and enquiry to create and interpret knowledge in the discipline.

Successful application of established techniques of research and enquiry to create and interpret knowledge in the discipline.

Some application of theory / knowledge but mostly correct and appropriate.

 

Limited application of theory / knowledge, with some applications incorrect or inappropriate.

Little evidence of application, or incorrect application.

 

Analysis and Evaluation (e.g. Clear, valid arguments supported by evidence, evidence for critical thinking) (30% weighting)

Excellent integration of complex argument, questioning, reflection and concepts. Clear and valid arguments supported by evidence. Showing independent thought and ability to place a personal value judgement on a range of statements / reports.

Substantial analysis and evaluation of evidence, concepts and theories, with sound attempt at integration. Balanced complex argument, adequately supported by evidence. Evidence for independent thinking, questioning and reflective

Attempts critical analysis, but tends to be descriptive. Some development of own argument, mainly supported by evidence, with some evidence of a questioning and reflective approach.

Mainly descriptive, with limited critical analysis. Argument poorly sustained with limited use of supporting evidence; little questioning or reflection

Descriptive; very little evidence of analysis/argument, questioning/reflection, or use of evidence.

 

 

approach with some personal value judgement.

 

Presentation

(in oral and written communication)

Communication, content and delivery of the regulatory process and correct information for a dossier on an investigational new drug

 

(Student should demonstrate understanding of this e.g. (background information of your chosen topic, the reasons for selecting the two journal articles for discussion, critical evaluation of the selected journal articles, in terms of the analytical methods used (and alternatives that could be used), results and conclusion, complete bibliographical details in Harvard format etc.) (30%)

Material is presented to a very high standard, all sources of information properly acknowledged and cited. No errors in spelling or sentence construction. A sophisticated and theoretically aware presentation that explores the methodological issues around the source material in an informed and perceptive way. Outstanding, enthusiastic and engaged delivery that makes the reader want to go further. Uses very effective ways of conveying information, concepts and ideas. Communicates difficult or abstruse ideas in a clear and intelligible way and responds to questions in a perceptive and interesting way.

Material is presented to a high standard, most sources of information properly acknowledged and cited. One or two errors in spelling and/or sentence construction. Good and theoretically aware presentation that explores the methodological issues around the source material in an informed and perceptive way. Excellent delivery that makes the reader want to go further.

Uses effective ways of conveying information, concepts and ideas. Communicates difficult or abstruse ideas in a clear and intelligible way and responds to questions in clearly.

Material is presented to a good standard, most sources of information properly acknowledged and cited. A few errors in spelling and/or sentence construction. A carefully explained and clear presentation that conveys a good sense of the sources used and the methodological issues around them. A clearly written report that shows an ability to engage with the reader and stakeholders Effective in conveying information, ideas, and concepts to the audience. Responds to questions directly in a coherent and informed manner.

Low standard of

presentation, few

references cited. Errors in

main body of the text and

in the reference list. May

contain several errors in

spelling and/or sentence

construction.

Information sources incorrectly/not cited, or from an inappropriate source. A coherent presentation but with some omissions or lack of clarity in the presentation of concepts and ideas and a lack of theoretical engagement. Relatively clear, with some engagement. Conveys information and some ideas in the report. Responses to assigned tasks are clear and coherent but limited.

Poor standard of presentation,

few references cited. Errors in

main body of the text and in the

reference list. May contain

significant errors in spelling

and/or sentence construction.

Many errors. Information sources incorrectly/not cited or from an inappropriate source. A descriptive list of sources, with little defined structure or analysis. There may be errors or material included may be irrelevant to the topic. Rambling and unstructured. Delivery of report is hard to follow and unintelligible.  The presentation