A supported liquid extraction-LC-MS/MS method for determination of GDC-0980 (Apitolisib), a dual small-molecule inhibitor of class 1A phosphoinositide 3-kinase and mammalian target of rapamycin, in human plasma

- GDC-0980 (Apitolisib) is a small molecule dual PI3K/mTor inhibitor.
- A SLE-LC-MS/MS analytical method was developed and validated for GDC-0980 in human plasma.
- Validation met criteria of the “Guidance for Industry” set by the FDA.
- Pharmacokinetic results of a phase I clinical trial are presented.