Anouk Donners

98 Chapter 5 25. Ramamurthy N, Kucharski C, McInerney, M, Chen, D, Morris M. Analytical Performance Evaluation of a Dedicated Calibrator and Controls for Emicizumab Quantification. ISTH Academy. 2019; Oral Presentation. 26. Krumb E, Fijnvandraat K, Makris M, Peyvandi F, Ryan A, Athanasopoulos A, Hermans C. Adoption of emicizumab (Hemlibra(R)) for hemophilia A in Europe: Data from the 2020 European Association for Haemophilia and Allied Disorders survey. Haemophilia. 2021; 27: 736-743. 27. Bowyer AE, Lowe AE, Tiefenbacher S. Laboratory issues in gene therapy and emicizumab. Haemophilia. 2021; 27: 142-147. 28. Amrani ME, Gerencser L, Huitema ADR, Hack CE, van Luin M, van der Elst KCM. A generic sample preparation method for the multiplex analysis of seven therapeutic monoclonal antibodies in human plasma or serum with liquid chromatography-tandem mass spectrometry. J Chromatogr A. 2021; 1655: 462489. 29. El Amrani M, Szanto CL, Hack CE, Huitema ADR, Nierkens S, van Maarseveen EM. Quantification of total dinutuximab concentrations in neuroblastoma patients with liquid chromatography tandem mass spectrometry. Anal Bioanal Chem. 2018; 410: 5849-5858. 30. European Medicines Agency. Guideline on bioanalytical method validation, 2011. https://www.ema. Accessed on 07-10-2021. 31. Fischer K, Donners AA, Urbanus RT, Kremer Hovinga IC, van Vulpen LF, R van der Valk P, van Galen KP, Uitslager N, Schutgens RE. Real-world Experience of Emicizumab Treatment Using Entire Vials Only. Res Pract Thromb Haemost. 2021; 5 (Suppl 2): Abstract Number: PB0677. 32. Bahar B, Tuncel AF, Holmes EW, Holmes DT. An interactive website for analytical method comparison and bias estimation. Clin Biochem. 2017; 50: 1025-1029. 33. Bowyer A, Kitchen S, Wardle R, Maclean R.. Severe Haemophilia A Plasma Artificially Spiked with Emicizumab and Recombinant Factor VIII Concentrates: Measurement by One-Stage and Chromogenic Factor VIII Assays. Res Pract Thromb Haemost. 2020; 4 (Suppl 1): Abstract Number: PB0505. 34. Pekrul I, Pfrepper C, Calatzis G, Giebl A, Siegemund A, Grutzner S, Spannagl M. Approximation of emicizumab plasma levels in emergency situations. A practical approach. Haemophilia. 2021; 27: e214e220. 35. Donners A, Rademaker CMA, Bevers LAH, Huitema ADR, Schutgens REG, Egberts TCG, Fischer K. Pharmacokinetics and Associated Efficacy of Emicizumab in Humans: A Systematic Review. Clin Pharmacokinet. 2021; 60: 1395-1406. 36. El Amrani M, Donners AAM, Graat G, Lentjes EG, Huisman A, Musson REA, van Maarseveen EM. Quantification of coagulation factor VIII in human plasma with liquid chromatography tandem mass spectrometry using a selective sample purification with camelid nanobodies. J Pharm Biomed Anal. 2019; 175: 112781. 37. Donners A, van Maarseveen EM, Weetink YRJ, El Amrani M, Fischer K, Rademaker CMA, Egberts TCG, Huisman A, Musson REA. Comparison between coagulation factor VIII quantified with one-stage activity assay and with mass spectrometry in haemophilia A patients: Proof of principle. Int J Lab Hematol. 2020; 42: 819-826. 38. Kushnir MM, Rockwood AL, Bergquist J. LC-MS/MS in clinical laboratories. Bioanalysis. 2013; 5: 5-6. 39. Ryman JT, Meibohm B. Pharmacokinetics of Monoclonal Antibodies. CPT Pharmacometrics Syst Pharmacol. 2017; 6: 576-588.