Repeat Analysis and Incurred Sample Reanalysis: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team
Journal Title: The AAPS Journal - Year 2014, Vol 16, Issue 6
Abstract
The A7 harmonization team (A7 HT), a part of the Global Bioanalysis Consortium (GBC), focused on reviewing best practices for repeat analysis and incurred sample reanalysis (ISR) as applied during regulated bioanalysis. With international representation from Europe, Latin America, North America, and the Asia Pacific region, the team first collated common practices and guidance recommendations and assessed their suitability from both a scientific and logistical perspective. Subsequently, team members developed best practice recommendations and refined them through discussions and presentations with industry experts at scientific meetings. This review summarizes the team findings and best practice recommendations. The few topics where no consensus could be reached are also discussed. The A7 HT recommendations, together with those from the other GBC teams, provide the basis for future international harmonization of regulated bioanalytical practices.
Authors and Affiliations
Eric Fluhler, Faye Vazvaei, Puran Singhal, Petra Vinck, Wenkui Li, Jignesh Bhatt, Theo de Boer, Ajai Chaudhary, Masahiro Tangiuchi, Vinicius Rezende, Dafang Zhong
Keywords
Related Articles
- EP ID EP681724
- DOI 10.1208/s12248-014-9644-1
- Views 65
- Downloads 0
Analyzing the Cryptome: Uncovering Secret Sequences
The mammalian cryptome consists of bioactive peptides generated by the proteolysis of precursor proteins. It is speculated that the cryptide repertoire increases the complexity of the proteome by an order of magnitude. C...
Ajulemic acid (IP-751): Synthesis, proof of principle, toxicity studies, and clinical trials
Ajulemic acid (CT-3, IP-751,1’,1’-dimethylheptyl-Δ8 acid) (AJA) has a cannabinoid-derived structure; however, there is no evidence that it produces psychotropic actions when given at therapeutic d...
Endocannabinoid signaling directs periimplantation events
An emerging concept in female reproduction is the role of endocannabinoids, a group of endogenously produced lipid mediators that bind to and activate cannabinoid receptors. Although adverse effects of cannabinoids in fe...
Application of the Biopharmaceutical Classification System in Clinical Drug Development—An Industrial View
The biopharmaceutical classification system (BCS) classifies compounds based on their solubility and permeability. Regulatory agencies and health organizations have utilized this classification system to allow dissolutio...
Prediction of Biliary Excretion in Rats and Humans Using Molecular Weight and Quantitative Structure–Pharmacokinetic Relationships
The aims were (1) to evaluate the molecular weight (MW) dependence of biliary excretion and (2) to develop quantitative structure–pharmacokinetic relationships (QSPKR) to predict biliary clearance (CLb) and perce...