02849nam 2200637 450 991014308130332120170809164159.01-118-67947-41-282-18827-597866121882750-470-45941-70-470-45940-9(CKB)1000000000773866(EBL)448903(OCoLC)441886965(SSID)ssj0000336032(PQKBManifestationID)11257820(PQKBTitleCode)TC0000336032(PQKBWorkID)10278577(PQKB)11609727(PQKBManifestationID)16032677(PQKB)22873253(MiAaPQ)EBC448903(MiAaPQ)EBC4037469(DLC) 2015299086(PPN)243291590(EXLCZ)99100000000077386620160617h20092009 uy 0engur|n|---|||||txtccrCompatibility of pharmaceutical products and contact materials safety considerations associated with extractables and leachables /Dennis JenkeHoboken, New Jersey :Wiley,2009.©20091 online resource (401 p.)Description based upon print version of record.0-470-28176-6 Includes bibliographical references and index.Nomenclature and central concepts -- Extractables, leachables, and the product life cycle -- Material screening and characterization -- The prototype stage -- The early development stage -- Late stage product development -- Submission -- Launch -- Product maintenance -- Retirement -- Focus on emerging concepts.Compatibility of Pharmaceutical Products and Contact Materials Dennis Jenke Important safety aspects of compatibility for therapeutic products and their manufacturing systems, delivery devices, and containers Compatibility of Pharmaceutical Products and Contact Materials helps pharmaceutical, toxicology, analytical, and regulatory affairs professionals assess the safety of leachable and extractable chemicals associated with drug product packaging, manufacturing systems, and devices. The most comprehensive resource available, its coverage includes the strategies, tactics, and regulDrugsContainersSafety measuresDrug delivery devicesSafety measuresDrugsContainersSafety measures.Drug delivery devicesSafety measures.615.19615/.190289Jenke Dennis895630MiAaPQMiAaPQMiAaPQBOOK9910143081303321Compatibility of pharmaceutical products and contact materials2000764UNINA