PHRM06010 2013 INTRODUCTION TO DRUG DISCOVERY AND DEVELOPMENT

General Details

Full Title
INTRODUCTION TO DRUG DISCOVERY AND DEVELOPMENT
Transcript Title
INTRO TO DRUG DISCOVERY
Code
PHRM06010
Attendance
N/A %
Subject Area
PHRM - Pharmaceutical Science
Department
ASCI - Applied Sciences
Level
06 - NFQ Level 6
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2013 - Full Academic Year 2013-14
End Term
2019 - Full Academic Year 2019-20
Author(s)
Declan Shelly, Tom Patton
Programme Membership
SG_SPHAR_C06 201300 Higher Certificate in Science in Pharmaceutical Science SG_SSCIE_H08 201600 Bachelor of Science (Honours) SG_SSCIE_C06 201600 Higher Certificate in Science SG_SSCIE_H08 201700 Bachelor of Science (Honours) SG_SSCIE_C06 201700 Higher Certificate in Science
Description

This module introduces students to historical and contemporary aspects of drug discovery and development and examines the importance of regulation within the pharmaceutical sector.

Learning Outcomes

On completion of this module the learner will/should be able to;

1.

Discuss the drug discovery process, from both historical and comtemperory perspective.

2.

Compare drug discovery from natural products and synthetic processes.

3.
Distinguish between medicines and non medicinal products.
4.
Describe the medicinal product development process and state the significant features attendant with each phase of this process.
5.
State the historical reasons for the introduction of regulations governing the manufacture and distribution of medicines.
6.

Explain how regulatory authorities use regulations to control and protect the industry.

Module Dependencies

Prerequisites
None
Co-requisites
None
Incompatibles
None

Indicative Syllabus

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.

Product definitions.

Drug development process - pre-clinical , clinical trials, product approval.

Content of the marketing authorisiation application (CTD - Europe, US, and Japan).

 

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
100 %

Coursework Assessment

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


Type Location Description Hours Frequency Avg Workload
Group Learning Flat Classroom Group Learning 2 Weekly 2.00
Independent Learning UNKNOWN Self Study 5 Weekly 5.00
Total Full Time Average Weekly Learner Contact Time 2.00 Hours

Module Resources

Non ISBN Literary Resources

None

Other Resources

Module Lecture Notes

Additional Information

None