Pharma

Extractable and Leachables material composition and supply chain for ICH Q3E compliance
ICH Q3E: E&L risks with Material Variability and Supply Chain
||,
ICH Q3E places strong emphasis on understanding and controlling extractables and leachables (E&L) risks throughout...
continue reading
Permitted Daily Exposure
Permitted Daily Exposure within EMA and ICH Framework
||,
Permitted Daily Exposure (PDE, also referred to as “permissible daily exposure”) is a health-based limit...
continue reading
Watching DNA Repair in Real Time: A Revolutionary New Sensor
||,
Watching DNA Repair in Real Time: A Revolutionary New Sensor Our DNA is under constant...
continue reading
Trump administration to allow medications to be purchased directly from pharma companies
||,
What is the TrumpRx platform? The Trump administration has been considering launching a government-operated website,...
continue reading
Breaking Barriers: Including Pregnant and Breastfeeding Individuals in Clinical Trials
||,
Clinical trials have long shaped the future of medicine. But for decades, one vital population...
continue reading
Understanding the Reflection Paper on the Qualification of Non-Mutagenic Impurities: A Regulatory Perspective
||,
Introduction In the complex world of pharmaceutical development, ensuring drug safety and efficacy is paramount....
continue reading
FDA Issues Draft Guidance on AI in Drugs and Devices
||,
FDA Releases Draft Guidance on AI in Drug and Medical Device Development The U.S. Food...
continue reading
Machine Learning in Early Prediction of Metabolism of Drugs
||,
Marta Lettieri, Virginia Carlucci and Marco Rodda have contributed to the latest edition of Computational...
continue reading
How Mario Draghi’s Vision for European Competitiveness Could Transform the Pharma Industry
||,
The pharmaceutical industry stands at the crossroads of significant transformation as Europe rethinks its global...
continue reading
New ERA Guideline released on March 2024 by EMA. What changes in the Environmental Risk Assessment of medicines (ERA)?
||,
What is the environmental impact assessment of active pharmaceutical ingredients? Environmental impact assessment of active...
continue reading