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CHMP
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7 Westferry Circus Canary Wharf London E14 4HB United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E-mail info@ema.europa.eu Website www. ema.europa.eu © European Medicines Agency, 2014 . Reproduction is authorised provided the source is acknowledged. 20 February 2014 1 EMA/CHMP/792679/2013 2 Committee for Medicinal Products for Human Use (CHMP ) 3 Concept Paper on revision of the points to consider on 4 pharmacokinetics and pharmacodynamics in the 5 development of antibacterial medicinal products 6 (CHMP /EWP /2655/99) and conversion to a CHMP 7 guideline 8 9 Agreed by Infectious Diseases Worki ng Party November 2013 Adopted by CHMP for release for consultation 20 February 2014 Start of public consultation 28 February 2014 End of consultation (deadline for comments) 31 May 2014 10 The proposed guid eline will replace CPMP/EWP/2655/99 11 12 Comments s hould be provided using this template . The completed comments form should be sent t o IDWP secretariat @ema.europa.eu 13 Keywords Pharmacokinetics; pha rmacodynamics; exposure -response; target attainment 14 15
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