Home banner
Divider
A-Z Index

Quick way to the find the information that you need...

More button
Register with FRAME

Although you do not need to register, any information you provide will be confidential and used only by FRAME to improve the website

Register button
Account Login
Forgot password?

ATLA - ISI
The Journal

 

Alternatives to Laboratory Animals - ATLA

Download latest issue button Download back issues button Subscribe to ATLA
Contact Us

Tel icon

Tel: +44 (0)115 9584740


Tel icon

Fax: +44 (0)115 9503570

Make an Enquiry

Preclinical testing strategies.


Olejniczak, K. Gunzel, P. and Bass, R.

Drug Information Journal, 35(2), 321-336 (2001).

Preclinical studies and testing strategies with and without the use of animal testing methods have the purpose of limiting risks whenever a new active substance is to be used as a medicinal product in humans. They should be designed in such a way as to achieve as early, risk-free, unproblematic, and economic a transition as possible from preclinical to clinical trials in medicinal products development. For this purpose the legitimate interests of subjects, patients, manufacturers (sponsors), and the scientific community as well as regulatory and competent authorities must be harmonized so as to achieve a course of action that is medicinally, ethically (also with respect to animal testing), and legally justified. The development of a new medicinal product is generally marked by a number of preclinical and clinical investigations; their sequential order with regard to contents and logic, the testing duration needed on an individual basis, and chronological overlaps when carrying out these studies are all to be determined As every new active substance is a separate entity investigations and testing strategies must be designed individually The principle of flowcharts described in this text facilitates the development of a testing strategy adapted to a certain medicinal product by using decision-tree methods. At the same time, the flowchart principle allows for a structuring of the necessary scientific discussion between preclinical and clinical investigators as well as between sponsor and authorizing authority.