Bioanalytical Method Validation Protocol
Validation protocol proving a method quantifies an analyte in the matrix it will actually see, under expectations that apply equally to nonclinical and clinical work. Covers selectivity against real interference, calibration and quality controls with the lower limit demonstrated rather than asserted, accuracy, precision and matrix effect across multiple lots, stability under every condition a sample will meet, and run acceptance and reassay rules fixed before any result is seen. Maps to ICH M10.
What a template is not
A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.
Bioanalytical method validation demonstrates that a method reliably quantifies an analyte in the matrix it will actually see. It is where nonclinical and clinical work meet, because the same harmonised expectations apply to both and the laboratory standard does not follow the study type. The frequent failure is validating in one matrix lot and one species, then analysing study samples that were never represented.
What's Inside
How to Use It
The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.
ICH M10 harmonises bioanalytical method validation and study sample analysis for nonclinical and clinical studies, covering selectivity, calibration, accuracy and precision, matrix effect, stability, carryover and incurred sample reanalysis, with the same expectations regardless of study type. It does not decide which range your study needs, which interferences are credible in your population, or when a partial validation suffices — those determinations belong to the laboratory and the sponsor. The protocol structure is SPEQ practitioner synthesis.