Our method development team specializes in developing and validating robust methods for the analysis of small molecules, proteins, peptides, and metabolites.
Since 1998, Micro Constants has developed over 1,600 LC/MS/MS, HPLC/UV, HPLC/FL, immunoassay (e.g., ELISA & Meso Scale Delivery) including more than 100 non-proprietary assay methods.
Following validation protocols enables us to accommodate our clients’ needs for the assay validation and ensure that the appropriate regulations (e.g., guidance documents) and industry standards are being followed.
All GLP methods are validated in accordance with the USFDA Guidance for Industry, Bioanalytical Method Validation and performed in accordance with USFDA, OECD and MHLW Good Laboratory Practice regulations.
Scientists working with HPLC who need to further their understanding of the technique in order to develop better methods faster.
A: Test method validation is the documented process of ensuring a pharmaceutical test method is suitable for its intended use.
A validated test method is one has been documented as selective, accurate, precise, and linear over a stated range.
Additional parameters and performance characteristics are often evaluated for methods of greater complexity.
The biological variation (BV) of the human body components examined in laboratory medicine (analytes) can be described as of three types, namely, variation over the span of life, predictable cyclical variation that can be daily, monthly or seasonal in nature, and random variation.
The biological variation occurring over a person’s lifetime is related with the physiological changes inherent to growth, aging, pregnancy, menopause, and other normal circumstances.