Method Development, Transfer, and Validation
- Reverse engineering and rapid transition between species as well as matrices
- Equipment selection based on molecule and sensitivity requirements, e.g., LC MS or ELISA kits
- Instrument optimization for relevant parameters, e.g., mass spectrometer ionization
- Considerations for target curve range, Cmax, Tmax, AUC as requested or published
- Identification of an appropriate blank matrix, anticoagulant, reference standard, and stable labeled internal standard as applicable
- Qualification and transfer from another laboratory or to new equipment within the same laboratory
- Adjustments of equipment conditions for robustness and straightforward method validation downstream
- Preparation of calibration standards and quality control samples as well as performing a test run
- Performing cross-validation using unknown quality control samples and incurred samples
- Fit for purpose full three-day LC MS or six-day ELISA based validation as per FDA guidance
- Process stability including, short term bench top, autosampler, and freeze-thaw
- Examination of method specificity, extraction recovery, carryover, matrix effect, matrix suppression, and other relevant parameters
- Stability testing of drugs and biomarkers in biological matrices at various time points
