Last modified: 31 May 2022 13:05
This course will provide an introduction to the key analytical methods used in drug development and how to develop methods consistent with the demands of the regulatory authorities. Students will gain hands-on experience of the techniques described.
| Study Type | Postgraduate | Level | 5 |
|---|---|---|---|
| Term | Second Term | Credit Points | 15 credits (7.5 ECTS credits) |
| Campus | Aberdeen | Sustained Study | No |
| Co-ordinators |
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A wide range of relevant analytical methods will be described including: titration; water analysis (Karl Fischer); MPLC, HPLC and HPLC-MS (normal and reverse phase, analytical and preparative); NMR spectroscopy; IR spectroscopy; UV-vis spectroscopy; metal analysis using ICPMS; ion chromatography for counter-ion analysis; GC, GC headspace and GC-MS.
The principles of method validation will be discussed within the framework of the regulatory expectations of ICH guidance. The factors to be considered in generating a certificate of analysis (CoA) will be considered. The students will gain hands-on experience of each of these techniques in the associated laboratory classes.
Information on contact teaching time is available from the course guide.
| Assessment Type | Summative | Weighting | 50 | |
|---|---|---|---|---|
| Assessment Weeks | 29 | Feedback Weeks | 29 | |
| Feedback |
In setting of a ‘client meeting presentation’. Maximum group size of 5. Marked on presentation, questions & peer assessment and data quality so that each student gets a unique grade. |
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| Knowledge Level | Thinking Skill | Outcome |
|---|---|---|
| Procedural | Apply | Understand the application of chromatographic techniques for pharmaceutical analysis. |
| Procedural | Create | Demonstrate the ability to conduct an independent analysis using GC, LC and other modern chromatographic techniques |
| Procedural | Evaluate | Gain an understanding of method development for the techniques described |
| Procedural | Evaluate | Understand and evaluate the parameters and requirements for method validation. |
| Reflection | Evaluate | Demonstrate the ability to prepare a certificate of analysis. |
| Assessment Type | Summative | Weighting | 50 | |
|---|---|---|---|---|
| Assessment Weeks | 32 | Feedback Weeks | 34 | |
| Feedback |
Solving structures based on spectra – each student will be provided a different set of spectra written feedback |
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| Knowledge Level | Thinking Skill | Outcome |
|---|---|---|
| Procedural | Analyse | Understand the application of spectroscopic techniques for pharmaceutical analysis. |
| Procedural | Evaluate | Understand and evaluate the parameters and requirements for method validation. |
| Procedural | Evaluate | Gain an understanding of method development for the techniques described |
There are no assessments for this course.
| Assessment Type | Summative | Weighting | ||
|---|---|---|---|---|
| Assessment Weeks | Feedback Weeks | |||
| Feedback | ||||
| Knowledge Level | Thinking Skill | Outcome |
|---|---|---|
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||
| Knowledge Level | Thinking Skill | Outcome |
|---|---|---|
| Procedural | Evaluate | Gain an understanding of method development for the techniques described |
| Procedural | Analyse | Understand the application of spectroscopic techniques for pharmaceutical analysis. |
| Procedural | Apply | Understand the application of chromatographic techniques for pharmaceutical analysis. |
| Reflection | Evaluate | Demonstrate the ability to prepare a certificate of analysis. |
| Procedural | Create | Demonstrate the ability to conduct an independent analysis using GC, LC and other modern chromatographic techniques |
| Procedural | Evaluate | Understand and evaluate the parameters and requirements for method validation. |
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