Preclinical safety testing of biotechnology-derived pharmaceuticals: understanding the issues and addressing the challenges.
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.
Brennan
Frank R
FR
Huntingdon Life Sciences, Woolley Rd, Alconbury, Huntingdon, Cambridgeshire PE28 4HS, UK. BrennanF@UKOrg.Huntingdon.com
Shaw
Leigh
L
Wing
Mark G
MG
Robinson
Christine
C
D000818:Animals; D000911:Antibodies, Monoclonal / Q000494:pharmacology; D001709:Biotechnology / Q000379:methods*; D004353:Drug Evaluation, Preclinical / Q000379:methods*; D017408:Guidelines as Topic; D006801:Humans; D010599:Pharmacokinetics; D011994:Recombinant Proteins / Q000494:pharmacology; D018456:Reproductive Medicine / Q000379:methods; D013678:Technology, Pharmaceutical / Q000379:methods; D018675:Toxicity Tests; D014612:Vaccines / Q000494:pharmacology
D000911:Antibodies, Monoclonal; D011994:Recombinant Proteins; D014612:Vaccines