Preclinical Development of Drug

Recommended Prerequisites

Pharmacology, Regulation on the Development of medicines.

Teaching Methods

Theorical lectures
laboratory work
Problem solving report
Synthesis work
Test

Final exam.

Learning Outcomes

Study set of steps that a new molecule has to overcome in its preclinical stage, in particular as regards their safety profile before entry into man. Equipping students with the skills needed for a critical assessment on the regulatory component underlying this type of testing.

Work Placement(s)

No

Syllabus

Importance of pre-clinical testing in clinical trials Model animals used in preclinical trials Models of drug development. Relationship between animal models and clinical research Experimental drug and standards on your route Pharmacological tests, toxicokinetic and pharmacokinetic studies
Acute toxicity studies Studies of repeated dose toxicity Determining the first dose in humans Exploratory clinical trials - testing MicroDose, single dose sub-therapeutic or anticipated therapeutic range and multiple dose trials Local tolerance study Genotoxicity studies Carcinogenicity studies Reproductive toxicity studies Clinical trials in the pediatric population immunotoxicity Toxicity tests with drug combination
Vivariums and legislation on the use of laboratory animals Implementation of experimental techniques in laboratory animals of several groups of drugs. Studies will be conducted in vivo and in vitro.

Head Lecturer(s)

Maria Margarida Coutinho de Seabra Castel-Branco Caetano

Assessment Methods

Assessment
Synthesis work: 15.0%
Mini Tests: 15.0%
Exam: 70.0%

Bibliography

Shayne Cox Gad. Preclinical Development Handbook – Toxicology, 2008, Wiley-Interscience – A John Wiley & Sons., Publication
Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and marketing authorization for Pharmaceuticals - M3(R2) - 11 June 2009
www.damienbove.com/.../ich-m3-r2-non-clinical-safety-studies-guidance-updated-by-emea/
Safety pharmacology studies for human pharmaceuticals (ICH S7A) - CPMP/ICH/539/00Nov 2000
Repeat-Dose Toxicity - CHMP/SWP/488313/07
Non-clinical guideline on drug-induced hepatotoxicity - CHMP/SWP/150115/06
Reproductive and Developmental Toxicity - Need for Non-Clinical Testing in Juvenile Animals on Human Pharmaceuticals for Paediatric Indications - CHMP/SWP/169215/05, 2008
Scientific Requirements for the Environmental Risk Assessment of Gene Therapy Medicinal Products - CHMP/GTWP/125491/06
Non-Clinical Development of Fixed Combinations of Medicinal Products
CHMP/SWP/258498/05 - Aug 2008