Guideline on the evaluation of the pharmacokinetics of ...

30 Churchill Place Canary Wharf London E14 5EU United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged. 17 December 2015 EMA/CHMP/83874/2014 Committee for Medicinal Products for Human use (CHMP) Guideline on the evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function Draft agreed by pharmacokinetics Working Party February 2014 Adopted by CHMP for release for consultation 20 February 2014 Start of public consultation 1 March 2014 End of consultation (deadline for comments) 31 august 2014 Agreed by pharmacokinetics Working Party October 2015 Adopted by CHMP 17 December 2015 Date for coming into effect 1 July 2016 This Guideline replaces 'Note

31 August 2014 . Agreed by Pharmacokinetics Working Party ... 17 December 2015 . Date for coming into effect : 1 July 2016 . This guideline replaces 'Note for guidance on the evaluation of the pharmacokinetics of medicinal ... in metabolism and active transport in the kidn ey, liver or gut, and in plasma protein binding , especially in patients ...

Tags:

  Evaluation, 2015, August, Pharmacokinetic, The evaluation of the pharmacokinetics

Information