Search results for " characterization"
Article
Early Communication with Regulators is Essential for SMEs
The quality data to be certified would include information on starting and raw materials, the manufacturing and characterization of the active substance, and the reproducibility of the manufacturing p…
Article
Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
“It would be primarily based on extensive characterization data from the reference products,” explained Nicklas Ekman of the Finnish Medicines Agency. “It would be detailed at an early stage of develo…
Article
FDA Seeks Metrics to Define Drug Quality
…ax oversight by supervisors, poorly maintained equipment and facilities, or poor product and process characterization, according to the Generic Pharmaceutical Association (GPhA) and the Pharmaceutica…
Article
Navigating Emerging Markets: Middle East and North Africa
The pharmaceutical industry grows despite conflict in the Middle East.
The Middle East and North Africa have been rocked in recent years by upheaval ranging from moderate protest to full…
Article
Biosimilars Development and Supply: How Complex Can the Process Be?
As the complex requirements of manufacturing biologics are manifold, it is important that biomanufacturing companies adopt quality-by-design principles.
Countries around the world face a gro…