•GMP专业意见,支持与加速准入计划有关的科学问题 •Review of GMP provisions in thecontext of ‘disruptive innovation’ and propose revisions to GMP guidanceinterlinking with EMA Innovation Task Force and similar initiatives, asappropriate. • 依“颠...
For further guidance reference is made to the “Reflection Paper for Laboratories That Perform The Analysis Or Evaluation Of Clinical Trial Samples.” (EMA/INS/GCP/532137/2010). 6. Incurred samples reanalysis The use of calibration standards and QC samples during validation may not mimic the ...
21 July 2011 EMEA/CHMP/EWP/192217/2009 Committee for Medicinal Products for Human Use (CHMP) Guideline on bioanalytical method validation Draft agreed by the Efficacy Working Party Adoption by CHMP for release for consultation End of consultation (deadline for comments) Agreed by Pharmacokinetics ...
Victoria Bell 1,3,* 1 Social Pharmacy and Public Health Laboratory, Faculty of Pharmacy, University of Coimbra, 3000-548 Coimbra, Portugal 2 Drug Development and Technology Laboratory, Faculty of Pharmacy, University of Coimbra, 3000-548 Coimbra, Portugal ...