Non Clinical Assays

Recommended Prerequisites

The recommended prerequisites include what is taught in the 1 st cycle courses in the area of Medicinal Chemistry, Chemical Sciences, Biochemistry, Bioanalytical and Medical Sciences, and other courses considered appropriate by the Master Coordination Board.

Teaching Methods

Lectures with a strong component of dialogue and application in practical cases, essentially using the audiovisual media ("data show").

Learning Outcomes

Study the set of steps that a new molecule has to overcome in its preclinical phase, particularly as regards its profile of pharmacological action and safety prior to entry into clinical studies. Provide the student with the skills needed for a critical evaluation on the part regulatory underpinning this type of testing. Skills: Analysis and synthesis, organization and planning, information management, group work, critical thinking, oral and written communication, Creativity, Environmental Concerns, Self-criticism and self-evaluation, Quality concerns.

Work Placement(s)

No

Head Lecturer(s)

Cláudia Margarida Gonçalves Cavadas

Assessment Methods

Assessment
Mini Tests: 10.0%
Synthesis work: 10.0%
Report of a seminar or field trip: 10.0%
Report of problem solving - scientific articles : 20.0%
Exam: 50.0%

Bibliography

Non-clinical guideline on drug-induced hepatotoxicity - CHMP/SWP/150115/06

Directive 86/609/EEC on the Protection of Animals Used for Experimental and Other Scientific Purposes- www.eceae.org/a1_directive.php

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

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