Hii,
I am doing a research to find out pharmaceuticals in blood and urine matrix. Please let me explain how I can calculate the LOD and LOQ of my developed method?
Should I prepare a matrix blank to calculate LOD? If yes ow many blanks are needed? Please explain me the experimental procedure.
There are different statistical answers depending on which regulatory body or which scientific areas / methods are being used. Once identified, you can look them up (often using a search engine such as GOOGLE).
Hi
Please check WADA guidelines (anti-doping guidelines):
WADA Technical Documents – TD2021INDEX (click on the link in pdf)
https://www.wada-ama.org/sites/default/files/resources/files/td2021_index_v4.0_wada_technical_document_index_clean_01_june_2021.pdf
DECISION LIMITS FOR THE CONFIRMATORY QUANTIFICATION OF EXOGENOUS THRESHOLD SUBSTANCES BY CHROMATOGRAPHY-BASED ANALYTICAL METHODS
https://www.wada-ama.org/sites/default/files/resources/files/td2021dl_final_eng_0.pdf
2021 Code Implementation Support Program Guidelines for the International Standard for Results Management
https://www.wada-ama.org/sites/default/files/resources/files/wada_isrm_guidelines_2021.pdf
Of course, if you want simply analyze any molecule level in human samples (blood, serum, plasma, urine) as a starting point for validation you can always use the guidelines by FDA and EMA. Its gold standard and state-of-the-art approach adopted not only by industry but by academia for many many years. Documents are very detailed and could be helpful.
Bioanalytical Method Validation Guidance for Industry
https://www.fda.gov/files/drugs/published/Bioanalytical-Method-Validation-Guidance-for-Industry.pdf
Guideline on bioanalytical method validation
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-bioanalytical-method-validation_en.pdf
Hope it helps
Best regards
Tomasz
- Badges
- Science method