Application of in-sample calibration curve methodology for regulated bioanalysis: Critical considerations in method development, validation and sample analysis.

•First application of in-sample calibration curve (ISCC) methodology in regulated bioanalysis.•Proposed method validation procedures/processes for ISCC–LC–MS/MS methods.•Successfully developed and validated an ISCC−LC–MS/MS method for BMS-984478.•Discussed the great potential of ISCC methodology for various quantitative applications.