LEADER 04967nam 22006615 450 001 9910254086203321 005 20200701172053.0 010 $a3-319-23558-3 024 7 $a10.1007/978-3-319-23558-5 035 $a(CKB)3710000000579413 035 $a(EBL)4335074 035 $a(SSID)ssj0001607032 035 $a(PQKBManifestationID)16317695 035 $a(PQKBTitleCode)TC0001607032 035 $a(PQKBWorkID)14894864 035 $a(PQKB)11416353 035 $a(DE-He213)978-3-319-23558-5 035 $a(MiAaPQ)EBC4335074 035 $a(PPN)191705926 035 $a(EXLCZ)993710000000579413 100 $a20160113d2016 u| 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aNonclinical Statistics for Pharmaceutical and Biotechnology Industries /$fedited by Lanju Zhang 205 $a1st ed. 2016. 210 1$aCham :$cSpringer International Publishing :$cImprint: Springer,$d2016. 215 $a1 online resource (705 p.) 225 1 $aStatistics for Biology and Health,$x1431-8776 300 $aDescription based upon print version of record. 311 $a3-319-23557-5 320 $aIncludes bibliographical references at the end of each chapters and index. 327 $aIntroduction 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. 330 $aThis book serves as a reference text for regulatory, industry and academic statisticians and also a handy manual for entry level Statisticians. Additionally it aims to stimulate academic interest in the field of Nonclinical Statistics and promote this as an important discipline in its own right. This text brings together for the first time in a single volume a comprehensive survey of methods important to the nonclinical science areas within the pharmaceutical and biotechnology industries. Specifically the Discovery and Translational sciences, the Safety/Toxiology sciences, and the Chemistry, Manufacturing and Controls sciences. Drug discovery and development is a long and costly process. Most decisions in the drug development process are made with incomplete information. The data is rife with uncertainties and hence risky by nature. This is therefore the purview of Statistics. As such, this book aims to introduce readers to important statistical thinking and its application in these nonclinical areas. The chapters provide as appropriate, a scientific background to the topic, relevant regulatory guidance, current statistical practice, and further research directions. 410 0$aStatistics for Biology and Health,$x1431-8776 606 $aStatistics  606 $aMedicine 606 $aPharmacology 606 $aStatistics for Life Sciences, Medicine, Health Sciences$3https://scigraph.springernature.com/ontologies/product-market-codes/S17030 606 $aMedicine/Public Health, general$3https://scigraph.springernature.com/ontologies/product-market-codes/H00007 606 $aPharmacology/Toxicology$3https://scigraph.springernature.com/ontologies/product-market-codes/B21007 615 0$aStatistics . 615 0$aMedicine. 615 0$aPharmacology. 615 14$aStatistics for Life Sciences, Medicine, Health Sciences. 615 24$aMedicine/Public Health, general. 615 24$aPharmacology/Toxicology. 676 $a615.1 702 $aZhang$b Lanju$4edt$4http://id.loc.gov/vocabulary/relators/edt 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910254086203321 996 $aNonclinical statistics for pharmaceutical and biotechnology industries$91523514 997 $aUNINA