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New Epub on Preclinical Safety Evaluation of Biopharmaceuticals | BioQuality.biz

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

Kooijman M, J K van Meer P, H M Moors E, Schellekens H, Expert Opin Drug Saf. 2012 Sep;11(5):797-801. Epub 2012 Aug 6., Utrecht University, Copernicus Institute of Sustainable Development, Innovation studies , Heidelberglaan 2, postbus 80115, 3508 TC, Utrecht , The Netherlands +31 30 253 6771 ; +31 30 251 2746 ; m.kooijman@uu.nl.


  • Due to complexity and other attributes of biopharmaceuticals, it was and is expected that “classical preclinical safety evaluation procedures applied to SMTs would not predict the adverse effects of biopharmaceuticals.” [ed. note: SMT is an abbreviation for Small Molecule Therapeutics]. “Therefore,” the authors go on to say, “until sufficient experience was gained, the preclinical safety evaluation of biopharmaceuticals was carried out on a case-by-case basis.”
  • This Epub reviews the past 30 years, since the first biopharmaceuticals were developed, of preclinical safety experience, and tracks its evolution. Their thoughts, opinions, and conclusions include:
    • Our knowledge has now reached the point that a “preclinical safety evaluation procedure suited to biopharmaceuticals” is now a reasonable hope
    • According to the authors, this experience “shows that, as result of the risk-averse behavior of regulators and industry, classical procedures were taken as starting point although state-of-the-art knowledge on biopharmaceuticals was directed towards creating a new procedure, driven by the specific properties of biopharmaceuticals.”
    • The authors criticize current Regulatory Guidance for the preclinical safety evaluation of biopharmaceuticals because, in their opinion, “it employs a checkbox approach.”
  • They conclude by reminding us that “The adverse effects induced by biopharmaceuticals are on-target or immune system-induced,” and therfore: “the preclinical safety evaluation should not be standardized, but rather driven by product specific safety concerns.”

To see the Abstract, and a link to obtain this paper:  http://www.ncbi.nlm.nih.gov/pubmed/22861668 

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