Transcription of Guideline on similar biological medicinal products ...
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Guideline on similar biological medicinal products ...
7 Westferry Circus Canary Wharf London E14 4HB United KingdomTelephone+44 (0)20 7418 8400 Facsimile +44 (0)20 7418 agency of the European Union European Medicines Agency, 2012. Reproduction is authorised provided the source is May 2012 EMA/CHMP/BMWP/403543/2010 Committee for medicinal products for Human Use (CHMP) Guideline on similar biological medicinal products containing monoclonal antibodies non-clinical and clinical issues Draft Agreed by similar biological medicinal products Working PartyOctober 2010 Adoption by CHMP for release for consultation18 November 2010 End of consultation (deadline for comments)
Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and ... This guidance specific for monoclonal antibodies complements the above guideline and ... (e.g. neutralization of a soluble ligand, receptor activation or blockade)
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