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ICH M10 Guidance: Harmonization and Modification to Bioanalytical Method Variation
Global regulatory standards govern bioanalytical method development, validation and the subsequent assays. When those standards are updated, industry stakeholders...
Internal Standard (IS) Variation Case Studies: Emerging from Three Common IS Challenges
The use of internal standards (IS) is essential for developing and applying liquid chromatography-tandem mass spectrometric (LC-MS/MS) quantitative bioanalytical...
Achieving consistency in process development of mRNA therapeutics
Selecting raw materials is one of the earliest steps in the development of mRNA vaccines and therapeutics. The materials you choose have the potential...