Regulatory density as a means to refine current regulatory approaches for increasingly complex medicines

Author:

Klein Kevin,Stolk Pieter,De Bruin Marie Louise,Leufkens Hubert

Publisher

Elsevier BV

Subject

Drug Discovery,Pharmacology

Reference24 articles.

1. Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004. https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:324:0121:0137:en:PDF. Published November 13, 2007. Accessed April 5, 2021

2. Health systems governance in Europe: the role of European Union Law and Policy;Mossialos,2010

3. Known knowns, known unknowns, unknown unknowns: the predicament of evidence-based policy;Pawson;Am J Eval,2011

4. Immunogenicity of therapeutic proteins. Part 3: impact of manufacturing changes;Sharma;Biotechnol Adv,2007

5. Drift, evolution, and divergence in biologics and biosimilars manufacturing;Ramanan;BioDrugs,2014

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