Pharmaceutical dosage forms are differentiated primarily by their route of administration and secondarily by other dosing parameters. Parenteral dosage forms are those dosage forms that are injected through the skin or other external boundary tissue, or implanted within the body, to allow the direct administration of the active drug substance(s) into blood vessels, organs, tissues, or lesions. Large-volume parenteral drug products (LVPs) are liquid parenterals that are packaged in unit doses of greater than 100 ml. LVPs are typically packaged in flexible (i.e. plastic) packaging, opening the possibility of substances that leach from the packaging and become drug product impurities. Due to their large volume and sometimes complex composition, LVPs can be difficult to test (screen) for unspecified leachables. This presentation introduces LVP’s as a pharmaceutical dosage form and introduces the concept of the AET Challenge.

This presentation was recorded on March 24 and is part of a series.