Bioanalytical Services

Introduction Under the harmonized ICH M10 guideline, which was adopted at Step 4 on May 24, 2022, issued by the […]

Introduction Effective Calibration Curve Design and Regression Weighting in LC-MS/MS bioanalysis requires matching the mathematical order of the calibration function

Introduction: Microsampling techniques in bioanalysis have moved well beyond the dried blood spot card, because modern drug development needs smaller

Introduction: Bioanalytical CRO Services for Gene Therapy provide the specialized analytical support needed to measure therapeutic agents, biomarkers, biological responses,

Introduction The Accuracy and Precision Requirements for a Validated Bioanalytical Method define the quantitative performance limits that analytical assays must

Introduction The fundamental distinction between a fit-for-purpose and a fully validated bioanalytical method is determined by the extent of experimental

Introduction: Choosing between analytical platforms is an important decision in biologic drug development because the assay ultimately determines what is

Introduction Delivering comprehensive Bioanalytical Support for an AAV Gene Therapy IND requires the validation of highly sensitive molecular and immunoassay

Introduction Bioanalytical CRO services for Phase I First-in-Human studies provide the quantitative bioanalytical infrastructure necessary to validate drug concentration assays,

Introduction The development of a multiplexed bioanalytical panel for a combination immunotherapy clinical program requires the simultaneous quantitative assessment of