What does a bioanalysis lab need to know to quote?
The purpose of the data sets almost everything else. Discovery work can use a fit-for-purpose method; GLP toxicokinetics and clinical studies use methods validated against ICH M10. The analyte and matrix decide the platform, the expected concentration range sets the sensitivity needed, and the sample count and timeline decide capacity. Reference standard availability is the most common hidden delay, so the brief asks about it.
What does ICH M10 cover?
ICH M10 (adopted 2022, final FDA guidance November 2022, in effect in the EU from January 2023) is the harmonized standard for validating chromatographic and ligand binding bioanalytical methods and for analyzing study samples. It applies to nonclinical toxicokinetic studies run under GLP, nonclinical PK studies used in place of clinical ones, and clinical trials.
For a chromatographic method, full validation covers selectivity, specificity, matrix effect, the calibration curve and range, accuracy, precision, carry-over, dilution integrity, stability and reinjection reproducibility. Accuracy should be within 15% of nominal, or 20% at the lower limit of quantification.
How much incurred sample reanalysis should you plan for?
Incurred sample reanalysis (ISR) repeats a portion of real study samples to show the method performs on them as it did in validation. Under ICH M10, plan for 10% of samples when a study has up to 1,000, plus 5% of the samples above 1,000. ISR passes when at least two thirds of the repeats agree within 20% for chromatographic assays, or 30% for ligand binding assays. Build these samples into the sample count and the budget.
LC-MS/MS or ligand binding assay?
Small molecules and many peptides are usually measured by LC-MS/MS; large proteins such as antibodies are often measured by ligand binding assays such as ELISA. The choice depends on the molecule, the sensitivity needed and the reagents available, so the planner records it as a decision. Biomarker assays often follow a fit-for-purpose approach rather than the drug-assay criteria; agree it with your team.
Frequently asked questions
What does ICH M10 require for full validation?
For chromatographic methods: selectivity, specificity, matrix effect, calibration curve and range, accuracy, precision, carry-over, dilution integrity, stability and reinjection reproducibility. Ligand binding assays have their own parameter set in the same guideline.
What are the ISR acceptance criteria?
Under ICH M10, at least two thirds of incurred sample repeats should agree within 20% for chromatographic assays, or within 30% for ligand binding assays.
How many samples need incurred sample reanalysis?
10% of study samples if there are 1,000 or fewer; if more, 100 plus 5% of the number above 1,000.
Does ICH M10 replace the FDA 2018 bioanalytical method validation guidance?
FDA issued M10 as final guidance in November 2022 for the studies it covers. Check with your regulatory lead which guidance applies to a specific study, especially biomarker work outside M10's scope.
Should I choose LC-MS/MS or ELISA?
It depends on the molecule and the sensitivity you need. LC-MS/MS is usual for small molecules; ligand binding assays are usual for large proteins. Ask the lab to justify the platform against your concentration range.
Is anything I type stored or shared?
No. The planner runs entirely in your browser. Nothing you enter is saved, sent to BioBridgeX, put in the page address or passed to analytics or AI services. Closing or refreshing the page clears it, so copy or print the plan before you leave.
Is the generated plan a protocol?
No. It organizes the requirements you entered into a structured outline and lists what is still undecided. It is not a validated protocol, it does not recommend sample sizes, and it does not establish GLP, GMP or regulatory compliance. Have the plan reviewed by qualified scientific, statistical, ethical and regulatory experts.
Related free tools
- Pharmacokinetic (PK) Study Planner: Species, dose levels, routes, groups, sampling time points, matrix and PK parameters as a PK study outline.
- GLP Toxicology Study Checklist: Modality, route, species, duration, milestone, material and questions for the CRO as a planning checklist.
- Dilution Calculator: C1V1 = C2V2 for any unknown, with stock and diluent volumes and the dilution factor.
- All study planners and every free tool on BioBridgeX.
Sources
- ICH M10: Bioanalytical method validation and study sample analysis (2022)
- FDA guidance: M10 Bioanalytical Method Validation and Study Sample Analysis (November 2022)
- ICH S3A Q&As: Focus on microsampling (2017)
This planner organizes requirements. It is not a validated protocol, does not recommend sample sizes, and does not establish GLP, GMP or regulatory compliance. Review every plan with qualified scientific, statistical, ethical and regulatory experts. Facts on this page last checked 27 October 2026.
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