2012 White Paper on Recent Issues in Bioanalysis And Alignment of Multiple Guidelines

Abstract

Over 400 professionals representing pharmaceutical companies, CROs, and multiple regulatory agencies participated in the 6th Workshop on Recent Issues in Bioanalysis (WRIB). Like the previous sessions, this event was in the format of a practical, focused, highly interactive and informative workshop aiming for high-quality, improved regulatory compliance and scientific excellence. Numerous 'hot' topics in bioanalysis of both small and large molecules were shared and discussed, leading to consensus and recommendations among panelists and attendees representing the bioanalytical community. The major outcome of this year's workshop was the noticeable alignment of multiple bioanalytical guidance/guidelines from different regulatory agencies. This represents a concrete step forward in the global harmonization of bioanalytical activities. The present 2012 White Paper acts as a practical and useful reference document that provides key information and solutions on several topics and issues in the constantly evolving world of bioanalysis.

The Decennial Index of The White Papers in Bioanalysis: ‘A Decade of Recommendations (2007–2016)’

“…Discussions surrounding biomarker assays and validation began in 2012, when it was recommended in order to avoid confusion with the term GLP (Good Laboratory Practices) in biomarker analysis, either 'regulated' or 'non-regulated' bioanalysis should be used as part of nonclinical and clinical biomarker studies [6]. Biomarker assay validation (BAV) requirements were deliberated in 2015, when it was established that exploratory and confirmatory biomarker categories are not always distinct.…”

“…In 2012, DBS was recognized as a valuable technique in certain instances. The limitations and challenges of DBS still needed to be explored and the community was encouraged to note of the outcomes of the IQ working group and others who have efforts directed at the DBS topic [6]. In 2013, a consensus had been reached on the major recommendations from the IQ Consortium Microsampling Workshop Group, but at that time, DBS implementation was recommended to be fit-for-purpose and with close communication with regulators [7].…”

“…This group was created and a consensus was attained at the 2011 WRIB and resultant White Paper: the pursuit of consistency among regulatory inspectors can be facilitated via appropriate training, meetings and constructive exchanges among countries [5]. The discussion on global harmonization of BMV Guidance/ Guidelines continued in 2012 when the regulatory agencies effort toward bioanalytical global harmonization was recognized by having multiple, but harmonized, b ioanalytical guidance documents/guidelines [6].…”

“…For small molecules, samples can be reinjected when a cause for a batch failure can be assigned, however, samples need to be reanalyzed when processed stability is surpassed or when no assignable cause is found. For large molecules, reanalysis applies when a batch fails [6].…”

Incurred sample stability of ASP3258 in the presence of its acyl glucuronide

“…Stability tests using incurred samples are called "incurred sample stability (ISS)" [5]. ISS is the subject of intense debate within Global Bioanalysis Consortium (GBC) [5], Global CRO Council for Bioanalysis (GCC) [6,7], European Bioanalysis Forum (EBF) [8], Workshop on Recent Issues in Bioanalysis (WRIB) [9,10], and Japan Bioanalysis Forum [11]. However, the optimum test items and study design are still obscure [12].…”