Preclinical Safety Testing of Biotechnology-derived Pharmaceuticals: Understanding the Issues and Addressing the Challenges

Overview

Journal Mol Biotechnol

Publisher Springer

Specialties Biotechnology
Molecular Biology

Date 2004 May 4

PMID 15122047

Citations 14

Authors

Frank R Brennan

Leigh Shaw

Mark G Wing

Christine Robinson

Affiliations

Soon will be listed here.

Abstract

The unique and complex nature of biotechnology-derived pharmaceuticals has meant that it is often not possible to follow the conventional safety testing programs used for chemicals, and hence they are evaluated on a case-by-case basis. Nonclinical safety testing programs must be rationally designed with a strong scientific understanding of the product, including its method of manufacture, purity, sequence, structure, species specificity, pharmacological and immunological effects, and intended clinical use. This knowledge, coupled with a firm understanding of the regulatory requirements for particular product types, will ensure that the most sensitive and regulatory-compliant test systems are used to optimize the chances of gaining regulatory approval for clinical testing or marketing authorization in the shortest possible time frame.

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