HPLC-MS/MS usually becomes the most suitable technique to allow rapid, selective, accurate and affordable quantitation of new chemical entities in plasma, serum, blood, urine, faeces and different tissues from biological matrices.
Lead optimization towards a preclinical drug candidate requires fit-for-purpose validated methods capable to provide fast data turnaround.
LC-MS bioanalytical assays include three major stages that need to be developed and optimized: sample pretreatment, chromatographic separation and mass spectrometric detection. We at AMSbiopharma realize that sometimes a good understanding of the chemistry of the analyte is not available at this stage, and this is where our skilled mass spectrometrists and our cutting-edge equipment make a difference to get success.
Bioanalytical HPLC-MS/MS methods transferred by the sponsor are also applied if requested. The strength of qualification/validation of bioanalytical methods is agreed and written in protocol studies approved by the sponsor, according to the purpose of the bioanalysis and its investment/risk-taking balances strategy. On-site QA audit of every study is carried out before report being issued.
More strength validation protocols such as those defined in ICH M10 draft guideline, FDA Bioanalytical Method Validation (Guidance for Industry) or EMA Guideline on bioanalytical method are also followed for the sample analysis of GLP nonclinical studies.