Conference Report: Us Fda/Ema Harmonization of Their Bioanalytical Guidance/Guideline And Activities of The Global Bioanalytical Consortium

Abstract

The 2011 annual conference of the American Association of Pharmaceutical Scientists, held in Washington DC, USA, hosted a roundtable entitled: 'Update of the US FDA/European Medicines Agency (EMA) harmonization of their bioanalytical guidance - Global Bioanalytical Consortium activity and impact on small and large molecules.' The roundtable was initiated with a presentation from CT Viswanathan on the history of the revision of the FDA guideline on bioanalytical method validation. It was followed by a presentation by Jan Welink who presented an update on the final European Medicines Agency guideline on bioanalytical method validation with relevance to ongoing harmonization efforts. The final presentation was by Fabio Garofolo on the progress of the Global Bioanalytical Consortium harmonization teams for small and large molecules. Brian Booth and Sam Haidar of the FDA updated the audience on the status of the revision of the FDA bioanalytical guidance. The roundtable was moderated by Stephen Lowes.

Quantitative determination of sarsasapogenin in rat plasma using liquid chromatography-tandem mass spectrometry

“…The method was validated for specificity, linearity, sensitivity, precision, accuracy, matrix effect, extraction recovery and stability according to the guidelines set by the United States Food and Drug Administration (FDA) [15]. Validation runs were conducted on three consecutive days.…”

“…In this paper, method was developed and validated according to the FDA bioanalytical guidelines [15], and finally successfully applied to a preclinical trial in rats.…”

Severe Decrease of Cyclosporine Levels in a Heart Transplant Recipient Receiving the Direct Thrombin Inhibitor Argatroban

“…Repeatability (CV , 15%) and reproducibility (CV , 15%) are in accordance with recommendations (EMA 2012). 2 The limit of detection and quantification is 25 and 50 ng/mL, respectively. As we noticed that it has been described that the determination of aminoglycosides monitoring using the EMIT technique can be interfered by Heparin treatment, 3 we decided to explore the effect of argatroban on cyclosporine EMIT determination.…”

“…Given the high hemorrhagic risk of this patient, argatroban was introduced on D15 (7:00 PM) as replacement anticoagulation because of its short elimination half-life. [1][2][3][4][5][6] A research of heparin-PF4 antibodies was requested.…”

Untitled

“…The EMA guideline on BMV was also intended to be part of global harmonization as it took into account the US FDA bioanalytical method validation guidance for industry (2001), different published papers such as the AAPS/FDA Crystal City III White Paper, and the AAPS workshop on incurred sample reproducibility, as well as EMA experience based on issues seen during review of dossiers and inspections. 1 In light of the necessity to comply with international standards in the highly regulated environment of drug development and submission of New Drug Applications (NDA) or Abbreviated New Drug Applications (ANDA), bioanalysis remains the primary source for quantitative measurements of active drug ingredients and their respective metabolites in biological matrices. Assays must therefore be suitable for the purpose of their respective applications.…”