ACE

PF6614: Advanced (Bio)Pharma Technology and Data Analysis

Credit Weighting: 10
No. of Students: Min 10, Max 50.
Pre-requisite(s): None
Co-requisite(s): PF6613
Teaching Period(s): Semester 2.
Teaching Methods: 8 x 3hr(s) Workshops (webinars, lectures and case studies); 76hr(s) Directed Study; 100hr(s) Other (self-directed study)
Module Co-ordinator: Prof Abina Crean, School of Pharmacy.
Lecturer(s): Staff, School of Pharmacy.
Module Objective: To provide students with knowledge related to emerging trends in (bio)pharma technology and data analysis.
Module Content: Process analytical Technology. Continuous Processing. Real-Time Release. Chemometrics. Quality by Design. Quality by Control. Assuring quality of personalised medicines and advanced therapies. Introduction to Mechanistic and Empirical models. Design of Experiments. Design Space. Process capability. Multi-variate Analysis (Principle component Analysis and Partial Least Squares).
Learning Outcome: On successful completion of this module, students should be able to:
  • Describe the advantages and challenges associated with emerging trends in (bio)pharma technology.
  • Discuss in detail one emerging area of (bio)pharma technology considering regularory and economical aspects.
  • Create a Design of experiments to address a specific query.
  • Analyse data sets to identify variability and trends.
  • Fit experimental data to mechanistic models to calculate equipment or formulation parameters.
Assessment: Total Marks 200: Continuous Assessment 200 marks (Data analysis assignments, 120 marks; In term test, 80 marks).
Compulsory Elements: Continuous Assessment. Oral if required.
Penalties (for late submission of course/project work etc.): Where work is submitted up to and including 7 days late, 5% of the total marks available shall be deducted from the mark achieved. Where work is submitted up to and including 14 days late, 10% of the total marks available shall be deducted from the mark achieved. Work submitted 15 days late or more shall be assigned a mark of zero.
Pass Standard and any Special Requirements for Passing Module: 50%.
End of Year Written Examination Profile: No Formal Written Examination.
Requirements for Supplemental Examination: Marks in passed element(s) of Continuous Assessment are carried forward, Failed element(s) of Continuous Assessment must be repeated (as prescribed by the School of Pharmacy).

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