Please note

This document only provides information for the academic year selected and does not form part of the student contract

School:

School of Applied Sciences

Credit Rating:

15

Level (including FHEQ):

M (FHEQ Level 7)

Graded or Non Graded:

Graded

Version Valid From:

2019-09-02

Module Leader:

Laura Waters

Version Number

2023.01

Learning Methods

Guided Independent Study

Tutorial and Project Supervision

Lecture

Synopsis

This module will consider the testing of drug substances and formulations in the Pharmaceutical Industry. A graduate analyst will be familiar with a wide range of analytical techniques but largely chemical in nature. This module will extend that knowledge to the testing of formulated pharmaceutical products and their other important … For more content click the Read More button below.

Learning Strategy

The students will receive guidance on the methods of analysis and their validation in lectures. The application of these systems within the pharmaceutical industry will be developed through guidance given in the class room environment and will be developed in the major assignment.

Outline Syllabus

A description of all the major dosage forms The role and function of excipients and their testing and clearanceApplication of analytical chemistry in high throughput screening of drug substances and drug metabolismScreening of drug substances and drug stability studiesValidation of methods and dataPreformulation.Tablet testingBiopharmaceutical analysis Dissolution studiesRheologyMicrobial spoilagePreservative efficacyParticle size … For more content click the Read More button below.

Learning Outcomes

On successful completion of this module students will
1.
have a critical understanding of analytical methods used in stability testing.
2.
have a comprehensive appreciation and understanding of the theory and practice of the physical testing of tablet and other formulations.
3.
have studied in depth understand the Quality control and Quality assurance regulations governing pharmaceutical analysis.
4.
design, with reference to regulatory guidelines, a robust analysis of a medicine in a complex matrix.
5.
apply pharmaceutical methods to the testing of pharmaceuticals.

Formative Assessment

Assessment 1: Written draft

Summative Assessment

Assessment 1: In-Class Test

Assessment 2: Written Assignment

Assessment Criteria

The major assignment will research a particular therapeutic area, and then focus on a particular drug in that area. The aim is to create a marketing authorisation application suitable for submission to the MHRA as would be prepared by a generic company. The sections that will be covered are preformulation, … For more content click the Read More button below.

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Reading List