LEADER 04809nam 22006495 450 001 9910165151003321 005 20200630131836.0 010 $a3-319-50186-0 024 7 $a10.1007/978-3-319-50186-4 035 $a(CKB)3710000001065024 035 $a(DE-He213)978-3-319-50186-4 035 $a(MiAaPQ)EBC4806862 035 $a(PPN)198869339 035 $a(EXLCZ)993710000001065024 100 $a20170216d2017 u| 0 101 0 $aeng 135 $aurnn|008mamaa 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aStatistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry /$fby Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju Zhang 205 $a1st ed. 2017. 210 1$aCham :$cSpringer International Publishing :$cImprint: Springer,$d2017. 215 $a1 online resource (XI, 379 p. 113 illus., 80 illus. in color.) 225 1 $aStatistics for Biology and Health,$x1431-8776 311 $a3-319-50184-4 320 $aIncludes bibliographical references at the end of each chapters and index. 327 $aChapter 1. Introduction -- Chapter 2. Statistical Methods for CMC Applications -- Chapter 3. Process Design: Stage 1 of the FDA Process Validation Guidance -- Chapter 4. Process Qualification: Stage 2 of the FDA Process Validation Guidance -- Chapter 5. GMP Monitoring and Continuous Process Verification: Stage 3 of the FDA Process Validation Guidance -- Chapter 6. Analytical Procedures -- Chapter 7. Specifications -- Chapter 8. Stability -- Chapter 9. Analytical Comparability and Similarity. 330 $aThis book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities. Statistical methods are presented with a focus on applications unique to the CMC in the pharmaceutical industry. The target audience consists of statisticians and other scientists who are responsible for performing statistical analyses within a CMC environment. Basic statistical concepts are addressed in Chapter 2 followed by applications to specific topics related to development and manufacturing. The mathematical level assumes an elementary understanding of statistical methods. The ability to use Excel or statistical packages such as Minitab, JMP, SAS, or R will provide more value to the reader. The motivation for this book came from an American Association of Pharmaceutical Scientists (AAPS) short course on statistical methods applied to CMC applications presented by four of the authors. One of the course participants asked us for a good reference book, and the only book recommended was written over 20 years ago by Chow and Liu (1995). We agreed that a more recent book would serve a need in our industry. Since we began this project, an edited book has been published on the same topic by Zhang (2016). The chapters in Zhang discuss statistical methods for CMC as well as drug discovery and nonclinical development. We believe our book complements Zhang by providing more detailed statistical analyses and examples. 410 0$aStatistics for Biology and Health,$x1431-8776 606 $aStatistics  606 $aPharmaceutical technology 606 $aPharmacy 606 $aStatistics for Life Sciences, Medicine, Health Sciences$3https://scigraph.springernature.com/ontologies/product-market-codes/S17030 606 $aPharmaceutical Sciences/Technology$3https://scigraph.springernature.com/ontologies/product-market-codes/B21010 606 $aPharmacy$3https://scigraph.springernature.com/ontologies/product-market-codes/F00008 615 0$aStatistics . 615 0$aPharmaceutical technology. 615 0$aPharmacy. 615 14$aStatistics for Life Sciences, Medicine, Health Sciences. 615 24$aPharmaceutical Sciences/Technology. 615 24$aPharmacy. 676 $a615.1 700 $aBurdick$b Richard K$4aut$4http://id.loc.gov/vocabulary/relators/aut$0103494 702 $aLeBlond$b David J$4aut$4http://id.loc.gov/vocabulary/relators/aut 702 $aPfahler$b Lori B$4aut$4http://id.loc.gov/vocabulary/relators/aut 702 $aQuiroz$b Jorge$4aut$4http://id.loc.gov/vocabulary/relators/aut 702 $aSidor$b Leslie$4aut$4http://id.loc.gov/vocabulary/relators/aut 702 $aVukovinsky$b Kimberly$4aut$4http://id.loc.gov/vocabulary/relators/aut 702 $aZhang$b Lanju$4aut$4http://id.loc.gov/vocabulary/relators/aut 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910165151003321 996 $aStatistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry$92155924 997 $aUNINA