Plerixafor
ICH
BLOOD
Blood samples were obtained from all subjects at the following time points: before dosing, at 1, 3, 8, 12, 24 and 48 h after injection. Blood samples were also obtained daily until discharge on day 7. Plasma from each sample was isolated and stored in −80°C condition until shipment. The analysis of plasma for the quantitation of plerixafor using a validated method by liquid chromatography with tandem mass spectrometry (LC-MS/MS) was performed by NorthEast Biolab (Hamden, CT, USA) in compliance with principles of Good Laboratory Practice (GLP) Standards as outlined the US FDA Title 21 CFR Part 58; Good Clinical Practice (US FDA & ICH GCP Guidance) Standards, the Declaration of Helsinki, and the US FDA Guidance for COVID-19 Studies. The data were acquired using Phoenix WinNonlin, Version 8.0.0.3716, Certara, St. Louis, MO, software and the following pharmacokinetic parameters were calculated: peak plasma concentration (C