News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
The use of internal standards (IS) is essential for developing and applying liquid chromatography-tandem mass spectrometric (LC-MS/MS) quantitative bioanalytical methods. As bioanalytical knowledge rapidly advances and regulatory requirements continue to harmonize globally, attention has shifted to focus on IS of chromatographic methods.
Global regulatory standards govern bioanalytical method development, validation and the subsequent assays. When those standards are updated, industry stakeholders should actively partake in their evolution and prepare for the ensuing changes.
For more product information visit WuXi AppTec.