Introduction to the Proposals from the Global Bioanalysis Consortium Harmonization Team
Journal Title: The AAPS Journal - Year 2014, Vol 16, Issue 6
Abstract
At the initiative of four regional professional organizations from Europe (European Bioanalysis Forum (EBF)) and North America (AAPS, Applied Pharmaceutical Analysis (APA) APA and Calibration & validation group (CVG—currently represented in GBC by Canadian Forum for Analytical and Bioanalytical Sciences CFABS), a letter was sent to the FDA and the European Medicine Agency (EMA)), formally requesting the health authorities and bioanalytical community to join hands and harmonize global bioanalysis scientific best practices. The need for global harmonization of the bioanalytical guidance was also supported by publishing this letter as an open letter [12], an initiative which was supported by many [13–15]. At the same time, the authors from aforementioned open letter together with additional representatives from these organizations (currently referred to as founding members), proposed to form an organization which brings together experts from the global bioanalytical community to discuss, share, and finally propose a harmonized view on bioanalytical best practices that could lead to a guidance: the Global Bioanalysis Consortium (GBC). A consensus was reached among around 280 delegates, including five Regulatory Agencies, during the 5th Workshop on Recent Issues in Bioanalysis (5th WRIB) in April 2010 on the main characteristic of what a “harmonization and Global Bioanalytical Guidance” should be based upon the following: science driven with inclusion of a rationale behind each requirement to prevent “box checking”. In addition, it should have a global perspective (not local issues), should not be prescriptive, and finally must get buy-in from all the countries [16]. From there, the GBC founding members proposed the mission of the organization [17] and reached out into the global bioanalytical community to build the GBC ensuring balanced representation from North America, Latin America, Europe/Middle East/Africa and Asia-Pacific.
Authors and Affiliations
Philip Timmerman, Mark Arnold, Binodh DeSilva, Fabio Garofolo, Michaela Golob, Peter van Amsterdam, Shinobu Kudoh, Puran Singhal, Daniel Tang, Maria Francesca Riccio, Rafael Barrientos, Shrinivas Savale, Tatsuo Kurokawa
Keywords
Related Articles
- EP ID EP681722
- DOI 10.1208/s12248-014-9609-4
- Views 74
- Downloads 0
On Average: Data Exploration Based on Means Can Be Misleading
The following is an extract from the NONMEM® code used to fit Eq. 20 to the data.
Genetic Polymorphisms of Metabolic Enzymes and the Pharmacokinetics of Indapamide in Taiwanese Subjects
To understand the genetic makeup and impact on pharmacokinetics (PK) in the Taiwanese population, we analyzed the pharmacogenetic (PG) profile and demonstrated its effects on enzyme metabolism using indapamide as an exam...
Pharmacokinetic and Pharmacodynamic Analysis of Hyperthermic Intraperitoneal Oxaliplatin-Induced Neutropenia in Subjects with Peritoneal Carcinomatosis
The objective of this study was to characterize the pharmacokinetics and the time course of the neutropenia-induced by hyperthermic intraperitoneal oxaliplatin (HIO) after cytoreductive surgery in cancer patients with pe...
Pulmonary Immunization of Guinea Pigs with Diphtheria CRM-197 Antigen as Nanoparticle Aggregate Dry Powders Enhance Local and Systemic Immune Responses
This study establishes the immune response elicited in guinea pigs after pulmonary and parenteral immunizations with diphtheria CRM-197 antigen (CrmAg). Several spray-dried powders of formalin-treated/untreated CrmAg nan...
Sequential Bioequivalence Trial Designs with Increased Power and Controlled Type I Error Rates
The online version of this article (doi:10.1208/s12248-013-9475-5) contains supplementary material, which is available to authorized users.