國立虎尾科技大學 |

Statistical applications for chemistry, manufacturing and controls (CMC) in the pharmaceutical industry

紀錄類型:	書目-語言資料,印刷品 : Monograph/item
正題名/作者:	Statistical applications for chemistry, manufacturing and controls (CMC) in the pharmaceutical industry/ by Richard K. Burdick ... [et al.].
其他作者:	Burdick, Richard K.
出版者:	Cham :Springer International Publishing : : 2017.,
面頁冊數:	xi, 379 p. :ill., digital ; : 24 cm.;
Contained By:	Springer eBooks
標題:	Pharmacology - Statistical methods. -
電子資源:	http://dx.doi.org/10.1007/978-3-319-50186-4
ISBN:	9783319501864

Statistical applications for chemistry, manufacturing and controls (CMC) in the pharmaceutical industry
Statistical applications for chemistry, manufacturing and controls (CMC) in the pharmaceutical industry[electronic resource] /by Richard K. Burdick ... [et al.]. - Cham :Springer International Publishing :2017. - xi, 379 p. :ill., digital ;24 cm. - Statistics for biology and health,1431-8776. - Statistics for biology and health..

Chapter 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.

This 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.

ISBN: 9783319501864

Standard No.: 10.1007/978-3-319-50186-4doiSubjects--Topical Terms:

1105497
Pharmacology
--Statistical methods.

LC Class. No.: RM287

Dewey Class. No.: 615.10727

Statistical applications for chemistry, manufacturing and controls (CMC) in the pharmaceutical industry
LDR:03048nam a2200337 a 4500 001 959122
003 DE-He213
005 20170828163059.0
006 m d
007 cr nn 008maaau
008 201118s2017 gw s 0 eng d
020 $a 9783319501864 $q (electronic bk.)
020 $a 9783319501840 $q (paper)
024 7 $a 10.1007/978-3-319-50186-4 $2 doi
035 $a 978-3-319-50186-4
040 $a GP $c GP
041 0 $a eng
050 4 $a RM287
072 7 $a PBT $2 bicssc
072 7 $a MBNS $2 bicssc
072 7 $a MED090000 $2 bisacsh
082 0 4 $a 615.10727 $2 23
090 $a RM287 $b .S797 2017
245 0 0 $a Statistical applications for chemistry, manufacturing and controls (CMC) in the pharmaceutical industry $h [electronic resource] / $c by Richard K. Burdick ... [et al.].
260 $a Cham : $c 2017. $b Springer International Publishing : $b Imprint: Springer,
300 $a xi, 379 p. : $b ill., digital ; $c 24 cm.
490 1 $a Statistics for biology and health, $x 1431-8776
505 0 $a Chapter 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.
520 $a This 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.
650 0 $a Pharmacology $x Statistical methods. $3 1105497
650 1 4 $a Statistics. $3 556824
650 2 4 $a Statistics for Life Sciences, Medicine, Health Sciences. $3 670172
650 2 4 $a Pharmaceutical Sciences/Technology. $3 768561
650 2 4 $a Pharmacy. $3 582411
700 1 $a Burdick, Richard K. $3 528641
710 2 $a SpringerLink (Online service) $3 593884
773 0 $t Springer eBooks
830 0 $a Statistics for biology and health. $3 888382
856 4 0 $u http://dx.doi.org/10.1007/978-3-319-50186-4
950 $a Mathematics and Statistics (Springer-11649)