Large volume parenteral drug products are characterized by high dose volumes administered to the patient. This results in challenges in extractable and leachable study approaches. This presentation highlights the expected challenges, which are characteristic for large volume parenteral leachable studies and introduces strategies to resolve and deal with these difficulties. Furthermore, a clear vision will be outlined, as well as an emphasis on differences with the more “classic” leachable studies.
This presentation was recorded on March 24 and is part of a series.