Module Details

Module Code: ZSCI C4105
Module Title: Assay Development
Title: Assay Development
Module Level:: 8
Credits:: 10
Module Coordinator: Paula Rankin
Module Author:: Brian ORourke (Science Staff)
Domains:  
Module Description: To develop separation and extraction strategies in the analysis of drugs in pharmaceutical preparations
 
Learning Outcomes
On successful completion of this module the learner will be able to:
# Learning Outcome Description
LO1 Develop spectroscopic and other methods in the principles of validation of an analytical method.
LO2 Validate the major extraction and separation techniques used in sample recovery
LO3 Explore the assay methods to determine contaminant degradation by-products using standard chromatographic techniques
LO4 Evaluate the methods used in the analysis of various drug delivery vehicles
Dependencies
Module Recommendations

This is prior learning (or a practical skill) that is recommended before enrolment in this module.
No recommendations listed
Co-requisite Modules
No Co-requisite modules listed
Additional Requisite Information
No Co Requisites listed
 
Indicative Content
Assay Development
• Discuss the principles of validation of an analytical method. • Evaluate the major extraction and separation techniques used in sample recovery • Develop assay methods separating out drug and primary metabolites using standard chromatographic methods • Explore the robustness of the methods in the analysis of sustained-release, multi-dose and other drug-delivery forms
Module Content & Assessment
Assessment Breakdown%
Continuous Assessment10.00%
Practical30.00%
End of Module Formal Examination60.00%

Assessments

Full Time

Continuous Assessment
Assessment Type Case Studies % of Total Mark 10
Timing n/a Learning Outcomes 1,4
Non-marked No
Assessment Description
Regular written examinations to evaluate student understanding of course content
No Project
Practical
Assessment Type Practical/Skills Evaluation % of Total Mark 30
Timing n/a Learning Outcomes 2,3
Non-marked No
Assessment Description
Solvent extraction, flocculation, Sep-pack® and pre-column separation. pKa separation.
End of Module Formal Examination
Assessment Type Formal Exam % of Total Mark 60
Timing End-of-Semester Learning Outcomes 1,4
Non-marked No
Assessment Description
Final year evaluation
Reassessment Requirement
Exam Board
It is at the discretion of the Examination Board as to what the qualifying criteria are.

SETU Carlow Campus reserves the right to alter the nature and timings of assessment

 

Module Workload

Workload: Full Time
Workload Type Workload Category Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Lecture Contact Assay/Analytical Method Development 12 Weeks per Stage 3.00 36
Practicals Contact Practical extractions followed by analytical determination. 12 Weeks per Stage 6.00 72
Independent Learning Non Contact Study best assay development methods 15 Weeks per Stage 9.47 142
Total Weekly Contact Hours 9.00
 
Module Resources
Recommended Book Resources
  • A. B. Lyons. (2017), Practical Standardization by Chemical Assay of Organic Drugs and Galenicals, 1st. Forgotten Books, [ISBN: 978-048428632].
  • S. Mathew. (2012), Analytical Method Development by HPLC For Starters, Kindle.
  • C.M Riley, T.W. Rosanske. (2018), Specification of Drug Substances and Products: Development and Validation of Analytical Methods, 1st. Elsevier, [ISBN: 978-00810131].
This module does not have any article/paper resources
This module does not have any other resources
Discussion Note: