Mass Spectrometry in GMP Environments: Enhancing QC and Compliance in Drug Development
In today’s highly regulated biopharmaceutical landscape, ensuring quality, safety, and efficacy across the drug development lifecycle is both...
AMSbiopharma completes its Innovation Plan, supported by Innova Pyme, achieving progress in services, technology, and entrepreneurial culture
AMSbiopharma presented today, in an online event, the results of its Innovation Plan, developed over the past 18...
Impurity Profiling in Pharmaceuticals: Analytical Methods and Compliance
Ensuring the safety, efficacy, and quality of pharmaceutical products requires a thorough understanding of the impurities that may...
Pharmacokinetics and Pharmacodynamics (PK/PD) Studies in Drug Development: From ADME Principles to Translational Applications
Understanding how a drug behaves in the body and how it exerts its therapeutic effects is essential for...
Pharma Quality Control Strategies for Drug Development and Regulatory Compliance
In pharmaceutical development, ensuring that products consistently meet predefined standards of identity, strength, purity, and quality it’s essential....
Preclinical Research in Drug Development: From Toxicology to Translational Insights
Before a new compound can be administered to humans, it must undergo a rigorous process to ensure its...
ICH Guidelines for Analytical Method Validation: Principles, Requirements and Industry Applications
In pharmaceutical development, validating analytical methods goes further than regulatory formality. It is a critical component of ensuring...
ICH Q3 Impurity Guidelines: Analytical Strategies for Safer Drug Development
Impurities in pharmaceuticals can compromise the safety, efficacy, and stability of a product. To safeguard public health, global...