Generic substitution
- PMID: 21988164
- PMCID: PMC3243006
- DOI: 10.1111/j.1365-2125.2011.03920.x
Generic substitution
References
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- Informal Working Group on Effective Prescribing. Report to the Secretary of State for Social Services. London: DHSS; 1983. Greenfield Report.
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- Department for Business Innovation and Skills. The pharmaceutical price regulation scheme. June 2009. Available at http://www.berr.gov.uk/files/file51657.pdf (last accessed 16 February 2011)
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- EMEA/CPMP. 2005. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. EMEA/CPMP/42832/05.
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- EMA/CPMP. 2010. Guideline on similar biological medicinal products containing monoclonal antibodies. EMA/CHMP/BMWP/403543/2010.
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- EMA/CPMP. 2010. Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use. EMA/CHMP/BMWP/86289/2010.
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