語系:
繁體中文
English
說明(常見問題)
圖資館首頁
登入
回首頁
切換:
標籤
|
MARC模式
|
ISBD
Statistical applications for chemist...
~
Burdick, Richard K.
Statistical applications for chemistry, manufacturing and controls (CMC) in the pharmaceutical industry
紀錄類型:
書目-電子資源 : Monograph/item
正題名/作者:
Statistical applications for chemistry, manufacturing and controls (CMC) in the pharmaceutical industryby 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:
PharmacologyStatistical methods.
電子資源:
http://dx.doi.org/10.1007/978-3-319-50186-4
ISBN:
9783319501864$q(electronic bk.)
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$q(electronic bk.)
Standard No.: 10.1007/978-3-319-50186-4doiSubjects--Topical Terms:
267176
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
:03048nmm a2200337 a 4500
001
507543
003
DE-He213
005
20170828163059.0
006
m d
007
cr nn 008maaau
008
171030s2017 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 :
$b
Springer International Publishing :
$b
Imprint: Springer,
$c
2017.
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
267176
650
1 4
$a
Statistics.
$3
182057
650
2 4
$a
Statistics for Life Sciences, Medicine, Health Sciences.
$3
274067
650
2 4
$a
Pharmaceutical Sciences/Technology.
$3
338426
650
2 4
$a
Pharmacy.
$3
218145
700
1
$a
Burdick, Richard K.
$3
183727
710
2
$a
SpringerLink (Online service)
$3
273601
773
0
$t
Springer eBooks
830
0
$a
Statistics for biology and health.
$3
558271
856
4 0
$u
http://dx.doi.org/10.1007/978-3-319-50186-4
950
$a
Mathematics and Statistics (Springer-11649)
筆 0 讀者評論
全部
電子館藏
館藏
1 筆 • 頁數 1 •
1
條碼號
館藏地
館藏流通類別
資料類型
索書號
使用類型
借閱狀態
預約狀態
備註欄
附件
000000138478
電子館藏
1圖書
電子書
EB RM287 S797 2017
一般使用(Normal)
在架
0
1 筆 • 頁數 1 •
1
多媒體
多媒體檔案
http://dx.doi.org/10.1007/978-3-319-50186-4
評論
新增評論
分享你的心得
Export
取書館別
處理中
...
變更密碼
登入