Transcription of Guideline on Comparability after a change in the ...
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Guideline on Comparability after a change in the ...
European Medicines Agency 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 7418 8613 E-mail: EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged London, 19 July 2007 Doc. Ref. EMEA/CHMP/BMWP/101695/2006 COMMITTEE FOR HUMAN MEDICINAL PRODUCTS (CHMP) Guideline ON Comparability OF BIOTECHNOLOGY-DERIVED MEDICINAL PRODUCTS after A change IN THE MANUFACTURING PROCESS NON-CLINICAL AND CLINICAL ISSUES DRAFT AGREED BY BMWP1 December 2006 ADOPTION BY CHMP FOR RELEASE FOR CONSULTATION January 2007 END OF CONSULTATION (DEADLINE FOR COMMENTS) April 2007 AGREED BY BMWP WORKING PARTY June 2007 ADOPTION BY CHMP July 2007 DATE FOR COMING INTO EFFECT 1 November 2007 This Guideline replaces Guideline on Comparability of medicinal products containing biotechnology-derived proteins as active substance (CPMP/3097/02)
It is assumed that the product’s physico-chemical properties and in vitro / in vivo biological activity are well characterised according to state of the art methods. ... • Posology, e.g., dosing regimen and route of administration, for instance, repeated administration via the subcutaneous route is more likely to be associated with ...
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