The lack of success of the implementation of new methods in drug development can be studied from an innovation perspective
Get full access to this article
View all access options for this article.
References
1.
Anon. (2010). Report from the Commission to the Council and the European Parliament: Sixth Report on the Statistics on the Number Of Animals Used for Experimental and Other Scientific Purposes in the Member States of the European Union, SEC(2010) 1107, 15pp. Brussels, Belgium: European Commission. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2010:0511:REV1:EN:PDF (Accessed 23.07.13).
2.
AbbottA. (2008). More than a cosmetic change. Nature, London438, 144–146.
3.
IgarashiT.I., NakaneS. & KitagawaT. (1995). Predictability of clinical adverse reactions of drugs by general pharmacology studies. Journal of Toxicological Sciences20, 77–92.
4.
OlsonH., BettonG., RobinsonD., ThomasK., MonroA., KolajaG., LillyP., SandersJ., SipesG., BrackenW., DoratoM., Van DeunK., SmithP., BergerB. & HellerA. (2000). Concordance of the toxicity of pharmaceuticals in humans and in animals. Regulatory Toxicology & Pharmacology32, 56–67.
5.
Van MeerP.J.K., KooijmanM., van der LaanJ.W., MoorsE.H.M. & SchellekensH. (2013). The value of non-human primates in the development of monoclonal antibodies. Nature Biotechnology31, 881–882.
6.
Anon. (1986). Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes. Official Journal of the European Union L358, 18.12.1986, 1–28.
7.
KooijmanM. (2013). Why Animals are Still Being Used in Drug Development: An Innovation System Perspective, 208pp. [PhD Thesis, Utrecht University.] Ede, The Netherlands: GVO Drukkers & Vormgevers B.V.
8.
FagerbergJ. (2006). Innovation: A guide to the literature. In The Oxford Handbook of Innovation, 1st edition (ed. FagerbergJ., MoweryD.C., & NelsonR.R.), pp. 1–26. Oxford, UK: University Press.
9.
EdquistC. (1997). Systems of Innovation: Technologies, Institutions, and Organizations, 432pp. Abingdon, Oxfordshire, UK: Routledge.
10.
LundvallB-Ä., JohnsonB., AndersenE.S. & DalumB. (2002). National systems of production, innovation and competence building. Research Policy31, 213–231.
11.
MarkardJ. & TrufferB. (2008). Technological innovation systems and the multi-level perspective: Towards an integrated framework. Research Policy37, 596–615.
12.
ScottW.R. (2008). Institutions and Organizations — Ideas and Interests, Third Edn, 266pp. Thousand Oaks, CA, USA: Sage Publications, Inc.
13.
ThorntonP.H., OcasioW. & LounsburyM. (2012). The Institutional Logics Perspective — A New Approach to Culture, Structure and Process, First Edn, 234pp. Oxford, UK: Oxford University Press.
14.
ReayT. & HiningsC.R. (2009). Managing the rivalry of competing institutional logics. Organization Studies30, 629–652.
15.
AlfordR.R. & FriedlandR. (1985). Powers of Theory: Capitalism, the State, and Democracy, 502pp. Cambridge, UK: Cambridge University Press.
16.
KooijmanM., van MeerP.J.K., MoorsE.H.M. & SchellekensH. (2012). Thirty years of preclinical safety evaluation of biopharmaceuticals: Did scientific progress lead to appropriate regulatory guidance?Expert Opinion on Drug Safety11, 797–801.
17.
KooijmanM., van MeerP.J.K., Gispen-de WiedC.C., MoorsE.H.M., HekkertM.P. & SchellekensH. (2013). Risk-based approach for the nonclinical development of ATMPs — useful strategy to realize science-driven regulatory drug testing?Regulatory Toxicology & Pharmacology67, 221–225.
18.
Van MeerP.J.K., KooijmanM., BrinksV., Gispen-de WiedC.C., Silva-LimaB., MoorsE.H.M. & SchellekensH. (2013). Immunogenicity of mAbs in non-human primates during nonclinical safety assessment. mAbs5, 810–816.