PED3003 : Clinical Pharmacology and Drug Development
- Offered for Year: 2018/19
- Module Leader(s): Dr Lindsey Ferrie
- Lecturer: Dr Sasha Gartside, Professor Paul Flecknell, Dr Ruben Thanacoody
- Owning School: Biomedical Sciences
- Teaching Location: Newcastle City Campus
|Semester 1 Credit Value:||10|
• To introduce students to the key concepts used in the study of clinical pharmacology.
• To improve student understanding of the processes involved in drug development including both pre-clinical and clinical phases of development.
• To introduce students to the importance of pharmaco-economics and pharmaco-vigilance in clinical pharmacology and the regulatory aspects of the pharmaceutical industry.
• To enable students to gain an insight into the workings of the pharmaceutical industry.
Outline Of Syllabus
The module comprises of lectures by leading experts from the pharmaceutical industry and academics with experience of drug development/ translational pharmacology. Lectures provide the requisite revision and background for an understanding in clinical pharmacology. Lectures will cover the following key aspects:
- Pre-clinical drug development.
- Animal models and in vivo techniques used in pre-clinical development.
- Ethical considerations in both pre-clinical and clinical drug development.
- Regulatory toxicology.
- Clinical trial methodology including assessing safety, pharmacokinetics and efficacy in patients.
- Critical evaluation of clinical trial data.
- Pharmaco-vigilance and risk management.
- Role of regulatory bodies in clinical pharmacology and drug development.
|Scheduled Learning And Teaching Activities||Lecture||12||1:00||12:00||N/A|
|Scheduled Learning And Teaching Activities||Small group teaching||1||1:00||1:00||Seminar|
|Guided Independent Study||Independent study||1||87:00||87:00||Private study|
Teaching Rationale And Relationship
Lectures will provide students with the new knowledge and information to support the learning outcomes of the module. Lectures will also provide students with an opportunity to gain a greater understanding of the pharmaceutical industry by promoting interaction with leading experts in the field of drug development. Seminar is an interactive opportunity to learn how to evaluate clinical trials data.
The format of resits will be determined by the Board of Examiners
|Written Examination||90||2||A||80||2 from 4 short answer 1 from 3 long essay style|
|Report||1||M||20||New drug evaluation report (2,000 words)|
Assessment Rationale And Relationship
The short answer written exam will assess student knowledge about different aspects of clinical pharmacology and drug development as well as written communication skills. The short answer exam will also assess the student's ability to think critically about key aspects involved in clinical pharmacology. The new drug evaluation report produced by students will assess information retrieval and critical analysis skills as well as computer literacy, problem solving and the ability to appropriately justify recommendations.
FMS Schools offering Semester One modules available as ‘Study Abroad’ will, where required, provide an alternative assessment time for examinations that take place after the Christmas vacation. Coursework with submissions dates after the Christmas vacation will either be submitted at an earlier date or at the same time remotely.
The form of assessment will not vary from the original.