Biotherapeutics require extensive characterization and quality control (QC) testing prior to product release. These tests are resource intensive, time-consuming, and require updating as manufacturing ...

The authors propose a novel approach in which physicians’ responsibility for inpatient stays is expressed through physician-specific attribution ratios informed by patient characteristics. Objectives: ...

New Peptide MAM (multi-attribute method) workflow for the BioAccord LC-MS System monitors product quality attributes that can affect efficacy and safety of innovator drugs and biosimilars. End-to-end ...

Potency assay development uses DoE and QbD to improve accuracy, consistency, and regulatory readiness in biologics testing.

Reliable identification of the physician–patient relationship is necessary for accurate evaluation. Standardization of evidence-based attribution methods is essential to improve the value of ...