References
- Frost & Sullivan. Global CRO Market, 2016 (2017).
- Wilkinson M , HarperB , PeacockJ , MorrisonR , GetzK. Assessing outsourcing oversight practices and performance. Ther. Innov. Regul. Sci.54(1), 158–166 (2020).
- Tufts CSDD. Outsourcing outpaces internal spending but remains tactical and reactive. Tufts CSDD Impact Reports21(2) (2019).
- Tsou JA . Managing biomarker outsourcing: CRO evaluation, streamline outsource process, and quality management. In: WeinerR, KelleyM (Eds). Translating Molecular Biomarkers into Clinical Assays. Springer, NY, USA (2016).
- Getz K . Trends driving clinical trials into large clinical care settings. Nat. Rev. Drug Discov.17(10), 703–704 (2018).
- Wang T , GusevAI. Ensuring quality and compliance in outsourcing of bioanalysis of clinical biomarkers. Bioanalysis9(7), 501–504 (2017).
- Yu X , GusevAI. CRO benchmarking for clinical biomarker analysis outsourcing. Bioanalysis11(14), 1309–1313 (2019).
- Pannee J , GobomJ , ShawLMet al. Round robin test on quantification of amyloid-beta 1–42 in cerebrospinal fluid by mass spectrometry. Alzheimers Dement.12(1), 55–59 (2016).
- Ray CA , ZhouL , TsoiJet al. A strategy for improving comparability across sites for ligand binding assays measuring therapeutic proteins. J. Pharm. Biomed. Anal.53(3), 729–734 (2010).
- Sommer U , MoralesJ , GroenewegenAet al. Implementation of highly sophisticated flow cytometry assays in multicenter clinical studies: considerations and guidance. Bioanalysis7(10), 1299–1311 (2015).
- Yoneyama T , KudoT , JinnoF , SchmidtER , KondoT. Retrospective data analysis and proposal of a practical acceptance criterion for inter-laboratory cross-validation of bioanalytical methods using liquid chromatography/tandem mass spectrometry. AAPS J.16(6), 1226–1236 (2014).
- Mokadem M , ZechnerJF , MargolskeeRF , DruckerDJ , AguirreV. Effects of Roux-en-Y gastric bypass on energy and glucose homeostasis are preserved in two mouse models of functional glucagon-like peptide-1 deficiency. Mol. Metab.3(2), 191–201 (2014).
- US FDA. Bioanalytical Method Validation Guidance for Industry (2018). https://www.fda.gov/downloads/drugs/guidances/ucm070107.Pdf
- R Core Team. R: a Language and Environment for Statistical Computing (2017). https://www.R-project.org/
- Lin LI . A concordance correlation coefficient to evaluate reproducibility. Biometrics45(1), 255–268 (1989).
- Giavarina D . Understanding Bland Altman analysis. Biochem. Med.25(2), 141–151 (2015).
- Gleason CR , JiQC , WickremsinheER. Evaluation of correlation between bioanalytical methods. Bioanalysis12(6), 419–426 (2020).
- Islam R , KarS , IslamC , FarmenR. Adaptation of commercial biomarker kits and proposal for ‘drug development kits’ to support bioanalysis: call for action. Bioanalysis10(12), 945–955 (2018).
- Mehta D , PurushothamaS , StevensonL. Parallelism: the foundation of biomarker assay development and validation. Bioanalysis10(12), 897–899 (2018).
- Lee JW , DevanarayanV , BarrettYCet al. Fit-for-purpose method development and validation for successful biomarker measurement. Pharm. Res.23(2), 312–328 (2006).
- Valentin MA , MaS , ZhaoA , LegayF , AvrameasA. Validation of immunoassay for protein biomarkers: bioanalytical study plan implementation to support pre-clinical and clinical studies. J. Pharm. Biomed. Anal.55(5), 869–877 (2011).
- Tu J , BennettP. Parallelism experiments to evaluate matrix effects, selectivity and sensitivity in ligand-binding assay method development: pros and cons. Bioanalysis9(14), 1107–1122 (2017).
- Stevenson LF , PurushothamaS. Parallelism: considerations for the development, validation and implementation of PK and biomarker ligand-binding assays. Bioanalysis6(2), 185–198 (2014).