Thirty years of preclinical safety evaluation of biopharmaceuticals: Did scientific progress lead to appropriate regulatory guidance?

Expert Opinion on Drug Safety

Volumn 11, Issue 5, 2012, Pages 797-801

  Kooijman, Marlous ^a   Van Meer, Peter J K ^b   Moors, Ellen H M ^a   Schellekens, Huub ^a,b  

^a UTRECHT UNIVERSITY   (Netherlands)

^b UTRECHT UNIVERSITY   (Netherlands)

Author keywords

biopharmaceuticals; case by case approach; checkbox approach; preclinical safety evaluation; regulation

Indexed keywords

SMALL MOLECULE TRANSPORT AGENT;

AVERSIVE BEHAVIOR; CARCINOGENICITY; DEVELOPMENTAL TOXICITY; DRUG INDUSTRY; DRUG SAFETY; DRUG SCREENING; EVOLUTION; IMMUNOGENICITY; NONHUMAN; PRACTICE GUIDELINE; REPRODUCTIVE TOXICITY; REVIEW;

ANIMALS; BIOLOGICAL AGENTS; BIOLOGICAL FACTORS; BIOPHARMACEUTICS; DRUG EVALUATION, PRECLINICAL; GUIDELINES AS TOPIC; HISTORY, 20TH CENTURY; HISTORY, 21ST CENTURY; HUMANS; LEGISLATION, DRUG; PHARMACOVIGILANCE;

EID: 84865489427     PISSN: 14740338     EISSN: 1744764X     Source Type: Journal    
DOI: 10.1517/14740338.2012.712110     Document Type: Review

References (22)

1. Teelmann K, Hohbach C, Lehmann H. Preclinical safety testing of speciesspecific proteins produced with recombinant DNA-techniques. An attempt to transfer current experience into future testing strategies. Arch Toxicol 1986;59:195-200 (Pubitemid 17034013)
2. Stoll RE. The preclinical development of biotechnology-derived pharmaceuticals: the PMA perspective. Pharmaceutical manufacturers association. Prog Clin Biol Res 1987;235:169-71
3. Dayan AD. Rationality and regulatory requirements - a view from Britain. Prog Clin Biol Res 1987;235:89-106
4. Zbinden G. Biotechnology products intended for human use, toxicological targets and research strategies. Prog Clin Biol Res 1987;235:143-59
5. Finkle BS. Genetically engineered drugs: toxicology with a difference. Prog Clin Biol Res 1987;235:161-7
6. European Economic Community. Pre-clinical biological safety testing on medicinal products derived from biotechnology (3BS13a), 1988
7. Hohbach C. Safety in biotechnology progress & problems, industrial point of view. In: D'Arcy PF, Harron DWG, editors. Proceedings of The First International Conference on Harmonisation: Brussels 1991. The Queen's University of Belfast, Belfast, Northern Ireland; 1992. p. 307-16
8. ICH. S6(R1) - Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals, 2011
9. Cavagnaro JA. Preclinical safety evaluation of biotechnology-derived pharmaceuticals. Nat Rev Drug Discov 2002;1:469-75 (Pubitemid 37361490)
10. ICH. Addendum to ICH S6: Preclinical safety evaluation of biotechnology-derived pharmaceuticals S6 (R1), 2009
11. Giezen TJ, Mantel-Teeuwisse AK, Meyboom RHB, et al. Mapping the safety profile of biologicals: a disproportionality analysis using the who adverse drug reaction database, vigibase. Drug Saf 2010;33:865-78
12. Haller CA, Cosenza ME, Sullivan JT. Safety issues specific to clinical development of protein therapeutics. Clin Pharmacol Ther 2008;84:624-7
13. Baumann A. Nonclinical development of biopharmaceuticals. Drug Discov Today 2009;14:1112-22
14. Baldrick P. Safety evaluation of biological drugs: what are toxicology studies in primates telling us? Regul Toxicol Pharmacol 2011;59:227-36
15. Arthur WB. Competing technologies, increasing returns, and lock-in by historical events. Econ J 1989;99:116-31
16. Hobson WC, Fuller GB. Species selection for safety evaluation of biotechnology products. Prog Clin Biol Res 1987;235:55-71
17. Dayan AD. Safety evaluation of biological and biotechnology-derived medicines. Toxicology 1995;105:59-68 (Pubitemid 26018108)
18. Serabian MA, Pilaro AM. Safety assessment of biotechnology-derived pharmaceuticals: ICH and beyond. Toxicol Pathol 1999;27:27-31 (Pubitemid 29075740)
19. Baumann A. Early development of therapeutic biologics-pharmacokinetics. Curr Drug Metab 2006;7:15-21
20. Bussiere JL, Martin P, Horner M, et al. Alternative strategies for toxicity testing of species-specific biopharmaceuticals. Int J Toxicol 2009;28:230-53
21. Dixit R, Iciek LA, McKeever K, et al. Challenges of general safety evaluations of biologics compared to small molecule pharmaceuticals in animal models. Expert Opin Drug Discov 2010;5:79-94
22. Bornstein GG, Klakamp SL, Andrews L, et al. Surrogate approaches in development of monoclonal antibodies. Drug Discov Today 2009;14:1159-65