| Message: | Since PK studies are pivotal in new drug discovery, the bioanalytical methods should be well developed and fully validated to ensure the reliability and accuracy of the studies. As a world leader in the industry of drug discovery, Creative Biolabs has extensive experience in in vivo pharmacokinetic method development and validation for a full range of platforms including HPLC, LC/MS/MS, GC/FID or GC/MS, ICP/MS, and various ligand binding assays (ELISA or other cell-based assays).
Method development and validation is an essential first step to ensure that targeted analytes of interest can be reliably detected and quantified for general sample analysis. When method development is done, the method should be validated to determine its suitability for its intended use, according to FDA, USP, EP or ICH guidelines. To choose the most appropriate analytical methods for the quantitative evaluation of drugs and their metabolites (analytes) and biomarkers are pivotal for the effective and successful conduct of nonclinical and/or biopharmaceutics pharmacology studies. Bioanalytical methods validation involves performing all of the processes which show that a specific method used for quantitative measurement of analytes in a certain biological matrix (e.g., blood, serum, plasma, or urine) is reliable and reproducible for the intended application. General parameters for bioanalytical methods validation include accuracy, precision, selectivity, sensitivity, reproducibility, stability, etc. |
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