MARC Record from harvard_bibliographic_metadata

LEADER: 03093cam a2200397Mi 4500
001 014016573-8
005 20140502160310.0
006 m o d
008 131008t20142014ne a ob 001 0 eng d
020 $a9780080983431 (electronic bk.)
020 $a008098343X (electronic bk.)
020 $z9780080983509
035 0 $aocn861537317
040 $aE7B$erda$beng$cE7B$dN$T$dOPELS$dYDXCP
050 14 $aRS189$b.S64 2014eb
072 7 $aMED$x071000$2bisacsh
082 04 $a615.19
245 00 $aSpecification of drug substances and products :$bdevelopment and validation of analytical methods /$cedited by Christopher M. Riley, Riley and Rabel Consulting Services, Maryville, MO, USA, Thomas W. Rosanske, T.W. Rosanske Consulting, Overland Park, KS, USA, Shelley R, Rabel Riley, Department of Natural Sciences, Northwest Missouri State University, Maryville, MO, USA; Riley and Rabel Consulting Services, Maryville, MO, USA.
264 1 $aAmsterdam :$bElsevier,$c[2014]
264 4 $c©2014
300 $a1 online resource (389 pages) :$billustrations.
336 $atext$2rdacontent
337 $acomputer$2rdamedia
338 $aonline resource$2rdacarrier
504 $aIncludes bibliographical references and index.
505 0 $aPart 1. Introduction -- part 2. Universal tests -- part 3. Specific tests : drug substance -- part 4. Specific tests : drug product -- part 5. Pharmacopeial methods -- part 6. Microbial methods -- part 7. Biological fluids.
588 $aDescription based on online resource; title from PDF title page (ebrary, viewed October 8, 2013).
520 $aSpecification of Drug Substances and Products: Development and Validation of Analytical Methods is a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development and validation of analytical methods. This book is intended as more than a review of new regional guidelines, existing regulatory guidance, and industry practices. It provides a hands-on guide to understanding and applying these in practice. The authors discuss critical issues, novel approaches, and future directions while also providing insight into how International Guidelines were developed and the rationale behind them. Guide to industry best practices of analytical methodologies used in the specification of new drug substances and products (e.g. DOE, QbD)Critical assessment of the application of ICH guidelines on method validation and specification setting, written by experts involved in the development and application of the guidelines to aid understanding of requirements and what is expected by regulatory authoritiesDirect applicability to the day-to-day activities in drug development and the potential to increase productivity.
650 0 $aDrugs$xAnalysis$xMethodology.
650 7 $aMEDICAL / Pharmacology$2bisacsh
700 1 $aRiley, Christopher M.
700 1 $aRosanske, Thomas W.
700 1 $aRiley, Shelley R. Rabel.
988 $a20140426
049 $aHMSS
906 $0OCLC