Drug Development

Year
1

Academic year
2016-2017

Code
02031818

Subject Area
Medicinal Chemistry

Language of Instruction
Portuguese

Other Languages of Instruction
English

Mode of Delivery
Face-to-face

Duration
SEMESTRIAL

ECTS Credits
6.0

Type
Elective

Level
Non Degree Course

Recommended Prerequisites

Not applicable.

Teaching Methods

Expositive classes and seminars delivered by specialists with students interaction according to what is expected at the PhD level.

Learning Outcomes

Creates the awareness of the chemical and process development required to move from laboratory-scale of pre-clinical assays to kilogram-scale of clinical trials.

Work Placement(s)

Syllabus

1. Drug Development Overview

2. Drug Substance Development

3. Drug Product Development

4. Regulatory – Drug Substance and Investigational drugs

5. Patents, Data Exclusivity and Product Life-Cycle

6. Safety and Efficacy Modules
7. Clinical trial phases
8. Drug Product – Module 3 ICH
9. Case studies.

Head Lecturer(s)

Luís Guilherme da Silva Arnaut Moreira

Assessment Methods

Assessment
Written report: 100.0%

Bibliography

The bibliography of this course will be given to the students by the industrial specialists involved