Concept Paper Discusses Update of Aspetic Processing Guidelines
March 2nd 2003The recently issued FDA concept paper about aseptic processing shows how the current guidelines could be expanded and makes recommendations for alternatives to traditional cleanroom installations such as isolator-equipped aseptic filling lines and blow?fill?seal equipment.
A Review of Classification of Emerging Excipients in Parenteral Medications
March 2nd 2003As parenteral drug delivery becomes more complex and sophisticated, excipients that can facilitate drug (or gene) delivery to specific therapeutic targets will be required. An overwhelming majority of these excipients are derived from natural sources.