PHRM06010 2019 INTRODUCTION TO DRUG DISCOVERY AND DEVELOPMENT

General Details

Full Title
INTRODUCTION TO DRUG DISCOVERY AND DEVELOPMENT
Transcript Title
INTRODUCTION TO DRUG DISCOVERY
Code
PHRM06010
Attendance
75 %
Subject Area
PHRM - Pharmaceutical Science
Department
LIFE - Life Sciences
Level
06 - NFQ Level 6
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Declan Shelly
Programme Membership
SG_SPHAR_B07 201900 Bachelor of Science in Pharmaceutical Science SG_SPHAR_H08 201900 Bachelor of Science (Honours) in Pharmaceutical Science SG_SSCIE_B07 201900 Bachelor of Science in Science SG_SSCIE_H08 201900 Bachelor of Science (Honours) in Science SG_SSCIE_C06 201900 Higher Certificate in Science 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.

Teaching and Learning Strategies

This module will be delivered full-time. It will include lectures and videos.This approach is expected to address student learning needs. Moodle will be used as a repository of educational resources.

Module Assessment Strategies

Students will be assessed using a range of assessment methods including essays, oral presentations, posters and  short answer questions.

The student must achieve 40% overall in order to pass the module.

Repeat Assessments

Students may repeat Continuous Assessment as required

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..

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 Class Discussion Formative Performance Evaluation - % OnGoing 1,2,3,4,5,6
2 Continuous Assessment Continuous Assessment Assessment 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

Journal Resources

None

Other Resources

Module Lecture Notes

Additional Information

None