LEADER 02601nam 2200505 450 001 9910271046603321 005 20180713081858.0 010 $a1-118-97113-2 010 $a1-118-97112-4 010 $a1-118-97114-0 035 $a(CKB)4330000000007784 035 $a(MiAaPQ)EBC5086821 035 $a(EXLCZ)994330000000007784 100 $a20171030h20182018 uy 0 101 0 $aeng 135 $aurcnu|||||||| 181 $2rdacontent 182 $2rdamedia 183 $2rdacarrier 200 00$aICH quality guidelines $ean implementation guide /$fedited by Andrew Teasdale, AstraZeneca, London, United Kingdom, David Elder, Consultant (fGSK), Hertford, Hertfordshire, SG14 2DE, United Kingdom, Raymond W. Nims, RMC Pharmaceutical Solutions, Inc., Longmont, CO, USA 210 1$aHoboken, New Jersey :$cWiley,$d2018. 210 4$dİ2018 215 $a1 online resource (722 pages) $cillustrations (some color) 311 $a1-118-97111-6 320 $aIncludes bibliographical references at the end of each chapters and index. 330 $a"Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies. Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines. Uses case studies to help readers understand and apply ICH guidelines. Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines. Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)"--$cProvided by publisher. 606 $aDrug development 606 $aDrugs$xTesting 606 $aDrugs$xQuality control 608 $aElectronic books. 615 0$aDrug development. 615 0$aDrugs$xTesting. 615 0$aDrugs$xQuality control. 676 $a615.19 686 $aMED071000$aTEC032000$aSCI013060$2bisacsh 702 $aTeasdale$b Andrew 702 $aElder$b David$g(David P.), 702 $aNims$b Raymond W. 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910271046603321 996 $aICH quality guidelines$92796933 997 $aUNINA