PHRM06010 2013 INTRODUCTION TO DRUG DISCOVERY AND DEVELOPMENT
This module introduces students to historical and contemporary aspects of drug discovery and development and examines the importance of regulation within the pharmaceutical sector.
On completion of this module the learner will/should be able to;
Discuss the drug discovery process, from both historical and comtemperory perspective.
Compare drug discovery from natural products and synthetic processes.
Explain how regulatory authorities use regulations to control and protect the industry.
Historical perspective on medicinal product development.
Development of pharmacoepias - BP, EU, US.
Development of pharmaceutical product from natural sources and via synthetic routes.
Pharmaceutical Regulations in the U.S. and the E.U.
International and national regulatory agencies - IMB, MHRA, EMEA, FDA.
Drug development process - pre-clinical , clinical trials, product approval.
Content of the marketing authorisiation application (CTD - Europe, US, and Japan).
Coursework & Assessment Breakdown
|Title||Type||Form||Percent||Week||Learning Outcomes Assessed|
|1||Formative and Summative Assessment Class Discussion||Formative||UNKNOWN||- %||OnGoing||1,2,3,4,5,6|
|2||Continuous Assessment Continuous Assessment||Continuous Assessment||UNKNOWN||100 %||OnGoing||1,2,3,4,5,6|
Full Time Mode Workload
|Group Learning||Flat Classroom||Group Learning||2||Weekly||2.00|
|Independent Learning||UNKNOWN||Self Study||5||Weekly||5.00|
Module Lecture Notes