
At ISC 2026, a 20-minute IP-RPLC–UV assay distinguished mRNA capping variants without mass spectrometry, matching a UHPLC–MS reference method.
In the most general sense, validation refers to a process that consists of at least four distinct components or steps: software, instruments, methods or procedures, and system suitability.
about 20 years ago
GMP and Phase I Clinical Trials: Streamlining the Critical Path?about 20 years ago
Team Effortabout 20 years ago
Rated PG: Pharmaceutical Guidance Suggestedabout 20 years ago
European Clinical Trial Regulations Undergo a Slow Revolutionabout 20 years ago
Moving Biotech Products from CBER to CDER: A Work in Progressabout 20 years ago
FDA Video Interview Conducted by Jill Wechsler, Washington Bureau Chiefabout 20 years ago
New Climateabout 20 years ago
2006: A Regulatory Odysseyabout 20 years ago
CDER?s Division of Post-Marketing Evaluation for Quality Assessment