大葉大學圖書館 |

Nonclinical statistics for pharmaceutical and biotechnology industries[electronic resource] /

紀錄類型:	書目-語言資料,印刷品 : Monograph/item
杜威分類號:	615.1072
書名/作者:	Nonclinical statistics for pharmaceutical and biotechnology industries/ edited by Lanju Zhang.
其他作者:	Zhang, Lanju.
出版者:	Cham : : Springer International Publishing :, 2016.
面頁冊數:	xxii, 698 p. : : ill. (some col.), digital ;; 24 cm.
Contained By:	Springer eBooks
標題:	Pharmacology - Statistical methods.
標題:	Biotechnology - Statistical methods.
標題:	Statistics.
標題:	Statistics for Life Sciences, Medicine, Health Sciences.
標題:	Medicine/Public Health, general.
標題:	Pharmacology/Toxicology.
ISBN:	9783319235585
ISBN:	9783319235578
內容註:	Introduction to Nonclinical Statistics for Pharmaceutical and Biotechnology Industries -- Regulatory Nonclinical Statistics -- How to be a good nonclinical statistician -- Statistical Methods for Drug Discovery -- High-throughput Screening Data Analysis -- Quantitative-Structure Activity Relationship Modeling and Cheminformatics -- GWAS for Drug Discovery -- Statistical applications in Design and Analysis of In-Vitro Safety Screening Assays -- Nonclinical safety assessment: an introduction for statisticians -- General Toxicology, Safety Pharmacology, Reproductive Toxicology and Juvenile Toxicology Studies -- Clinical Assays for Biological Macromolecules -- Recent Research Projects by FDA's Pharmacology and Toxicology Statistics Team -- Design and evaluation of drug combination studies -- Biomarkers -- Overview of Drug Development and Statistical Tools for Manufacturing and Testing -- Assay Validation -- Lifecycle Approach to Bioassay -- Quality by Design: Building Quality into Products and Processes -- Process Validation -- Acceptance Sampling -- Process Capability and Statistical Process Control -- Statistical Considerations for Stability and the Estimation of Shelf Life -- In Vitro Dissolution Testing: Statistical Approaches and Issues -- Assessing Content Uniformity -- Chemometrics and Predictive Modelling -- Statistical Methods for Comparability Studies.
摘要、提要註:	This book serves as a reference text for regulatory, industry and academic statisticians and also a handy manual for entry level Statisticians. Additionally it aims to stimulate academic interest in the field of Nonclinical Statistics and promote this as an important discipline in its own right. This text brings together for the first time in a single volume a comprehensive survey of methods important to the nonclinical science areas within the pharmaceutical and biotechnology industries. Specifically the Discovery and Translational sciences, the Safety/Toxiology sciences, and the Chemistry, Manufacturing and Controls sciences. Drug discovery and development is a long and costly process. Most decisions in the drug development process are made with incomplete information. The data is rife with uncertainties and hence risky by nature. This is therefore the purview of Statistics. As such, this book aims to introduce readers to important statistical thinking and its application in these nonclinical areas. The chapters provide as appropriate, a scientific background to the topic, relevant regulatory guidance, current statistical practice, and further research directions.
電子資源:	http://dx.doi.org/10.1007/978-3-319-23558-5

Nonclinical statistics for pharmaceutical and biotechnology industries[electronic resource] /
Nonclinical statistics for pharmaceutical and biotechnology industries[electronic resource] /edited by Lanju Zhang. - Cham :Springer International Publishing :2016. - xxii, 698 p. :ill. (some col.), digital ;24 cm. - Statistics for biology and health,1431-8776. - Statistics for biology and health..

Introduction to Nonclinical Statistics for Pharmaceutical and Biotechnology Industries -- Regulatory Nonclinical Statistics -- How to be a good nonclinical statistician -- Statistical Methods for Drug Discovery -- High-throughput Screening Data Analysis -- Quantitative-Structure Activity Relationship Modeling and Cheminformatics -- GWAS for Drug Discovery -- Statistical applications in Design and Analysis of In-Vitro Safety Screening Assays -- Nonclinical safety assessment: an introduction for statisticians -- General Toxicology, Safety Pharmacology, Reproductive Toxicology and Juvenile Toxicology Studies -- Clinical Assays for Biological Macromolecules -- Recent Research Projects by FDA's Pharmacology and Toxicology Statistics Team -- Design and evaluation of drug combination studies -- Biomarkers -- Overview of Drug Development and Statistical Tools for Manufacturing and Testing -- Assay Validation -- Lifecycle Approach to Bioassay -- Quality by Design: Building Quality into Products and Processes -- Process Validation -- Acceptance Sampling -- Process Capability and Statistical Process Control -- Statistical Considerations for Stability and the Estimation of Shelf Life -- In Vitro Dissolution Testing: Statistical Approaches and Issues -- Assessing Content Uniformity -- Chemometrics and Predictive Modelling -- Statistical Methods for Comparability Studies.

This book serves as a reference text for regulatory, industry and academic statisticians and also a handy manual for entry level Statisticians. Additionally it aims to stimulate academic interest in the field of Nonclinical Statistics and promote this as an important discipline in its own right. This text brings together for the first time in a single volume a comprehensive survey of methods important to the nonclinical science areas within the pharmaceutical and biotechnology industries. Specifically the Discovery and Translational sciences, the Safety/Toxiology sciences, and the Chemistry, Manufacturing and Controls sciences. Drug discovery and development is a long and costly process. Most decisions in the drug development process are made with incomplete information. The data is rife with uncertainties and hence risky by nature. This is therefore the purview of Statistics. As such, this book aims to introduce readers to important statistical thinking and its application in these nonclinical areas. The chapters provide as appropriate, a scientific background to the topic, relevant regulatory guidance, current statistical practice, and further research directions.

ISBN: 9783319235585

Standard No.: 10.1007/978-3-319-23558-5doiSubjects--Topical Terms:

655720
Pharmacology
--Statistical methods.

LC Class. No.: RS57

Dewey Class. No.: 615.1072

Nonclinical statistics for pharmaceutical and biotechnology industries[electronic resource] /
LDR:03620nam a2200337 a 4500 001 456376
003 DE-He213
005 20160818133345.0
006 m d
007 cr nn 008maaau
008 161227s2016 gw s 0 eng d
020 $a 9783319235585 $q (electronic bk.)
020 $a 9783319235578 $q (paper)
024 7 $a 10.1007/978-3-319-23558-5 $2 doi
035 $a 978-3-319-23558-5
040 $a GP $c GP
041 0 $a eng
050 4 $a RS57
072 7 $a PBT $2 bicssc
072 7 $a MBNS $2 bicssc
072 7 $a MED090000 $2 bisacsh
082 0 4 $a 615.1072 $2 23
090 $a RS57 $b .N812 2016
245 0 0 $a Nonclinical statistics for pharmaceutical and biotechnology industries $h [electronic resource] / $c edited by Lanju Zhang.
260 $a Cham : $b Springer International Publishing : $b Imprint: Springer, $c 2016.
300 $a xxii, 698 p. : $b ill. (some col.), digital ; $c 24 cm.
490 1 $a Statistics for biology and health, $x 1431-8776
505 0 $a Introduction to Nonclinical Statistics for Pharmaceutical and Biotechnology Industries -- Regulatory Nonclinical Statistics -- How to be a good nonclinical statistician -- Statistical Methods for Drug Discovery -- High-throughput Screening Data Analysis -- Quantitative-Structure Activity Relationship Modeling and Cheminformatics -- GWAS for Drug Discovery -- Statistical applications in Design and Analysis of In-Vitro Safety Screening Assays -- Nonclinical safety assessment: an introduction for statisticians -- General Toxicology, Safety Pharmacology, Reproductive Toxicology and Juvenile Toxicology Studies -- Clinical Assays for Biological Macromolecules -- Recent Research Projects by FDA's Pharmacology and Toxicology Statistics Team -- Design and evaluation of drug combination studies -- Biomarkers -- Overview of Drug Development and Statistical Tools for Manufacturing and Testing -- Assay Validation -- Lifecycle Approach to Bioassay -- Quality by Design: Building Quality into Products and Processes -- Process Validation -- Acceptance Sampling -- Process Capability and Statistical Process Control -- Statistical Considerations for Stability and the Estimation of Shelf Life -- In Vitro Dissolution Testing: Statistical Approaches and Issues -- Assessing Content Uniformity -- Chemometrics and Predictive Modelling -- Statistical Methods for Comparability Studies.
520 $a This book serves as a reference text for regulatory, industry and academic statisticians and also a handy manual for entry level Statisticians. Additionally it aims to stimulate academic interest in the field of Nonclinical Statistics and promote this as an important discipline in its own right. This text brings together for the first time in a single volume a comprehensive survey of methods important to the nonclinical science areas within the pharmaceutical and biotechnology industries. Specifically the Discovery and Translational sciences, the Safety/Toxiology sciences, and the Chemistry, Manufacturing and Controls sciences. Drug discovery and development is a long and costly process. Most decisions in the drug development process are made with incomplete information. The data is rife with uncertainties and hence risky by nature. This is therefore the purview of Statistics. As such, this book aims to introduce readers to important statistical thinking and its application in these nonclinical areas. The chapters provide as appropriate, a scientific background to the topic, relevant regulatory guidance, current statistical practice, and further research directions.
650 0 $a Pharmacology $x Statistical methods. $3 655720
650 0 $a Biotechnology $x Statistical methods. $3 655721
650 1 4 $a Statistics. $3 145349
650 2 4 $a Statistics for Life Sciences, Medicine, Health Sciences. $3 464109
650 2 4 $a Medicine/Public Health, general. $3 463494
650 2 4 $a Pharmacology/Toxicology. $3 463455
700 1 $a Zhang, Lanju. $3 655719
710 2 $a SpringerLink (Online service) $3 463450
773 0 $t Springer eBooks
830 0 $a Statistics for biology and health. $3 464952
856 4 0 $u http://dx.doi.org/10.1007/978-3-319-23558-5
950 $a Mathematics and Statistics (Springer-11649)