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 72
- Downloads 0
Aqueous and cosolvent solubility data for drug-like organic compounds
Recently 2 QSPR-based in silico models were developed in our laboratories to predict the aqueous and non-aqueous solubility of drug-like organic compounds. For the intrinsic aqueous solubility model, a set of 321 structu...
Neuronal nicotinic acetylcholine receptor expression and function on nonneuronal cells
Of the thousands of proven carcinogens and toxic agents contained within a cigarette, nicotine, while being the addictive agent, is often viewed as the least harmful of these compounds. Nicotine is a lipophilic molecule...
Role of morphine's metabolites in analgesia: Concepts and controversies
The metabolites of morphine, morphine-6-glucuronide (M6G) and morphine-3-glucuronide (M3G), have been extensively studied for their contribution to clinical effects following administration of morphine. Those contributio...
Challenges in Development of Nanoparticle-Based Therapeutics
In recent years, nanotechnology has been increasingly applied to the area of drug development. Nanoparticle-based therapeutics can confer the ability to overcome biological barriers, effectively deliver hydrophobic drugs...
The Utility of Modeling and Simulation Approaches to Evaluate Immunogenicity Effect on the Therapeutic Protein Pharmacokinetics
While therapeutic proteins (TP), particularly recombinant human proteins and fully human monoclonal antibodies, are designed to have a low immunogenic potential in humans, a clinical immune response does sometimes occur...