LEADER 04201nam 22006855 450 001 996418271003316 005 20200701090609.0 010 $a3-030-37693-1 024 7 $a10.1007/978-3-030-37693-2 035 $a(CKB)4100000010661139 035 $a(DE-He213)978-3-030-37693-2 035 $a(MiAaPQ)EBC6134238 035 $a(PPN)243227558 035 $a(EXLCZ)994100000010661139 100 $a20200314d2020 u| 0 101 0 $aeng 135 $aurnn#008mamaa 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aStatistics in Clinical and Observational Vaccine Studies$b[electronic resource] /$fby Jozef Nauta 205 $a2nd ed. 2020. 210 1$aCham :$cSpringer International Publishing :$cImprint: Springer,$d2020. 215 $a1 online resource 225 1 $aSpringer Series in Pharmaceutical Statistics,$x2366-8695 311 $a3-030-37692-3 327 $a1.The Interplay Between Microorganisms and the Immune System -- 2. Analysis of Immunogenicity Data -- 3. Vaccine Field Studies -- 4. Correlates of Protection -- 5. Analysis of Vaccine Safety Data. 330 $aThis book offers an overview of the statistical methods used in clinical and observational vaccine studies. Pursuing a practical rather than theoretical approach, it presents a range of real-world examples with SAS codes, making the application of the methods straightforward. This revised edition has been significantly expanded to reflect the current interest in this area. It opens with two introductory chapters on the immunology of vaccines to provide readers with the necessary background knowledge. It then continues with an in-depth exploration of the analysis of immunogenicity data. Discussed are, amongst others, maximum likelihood estimation for censored antibody titers, ANCOVA for antibody values, analysis of data of equivalence, and non-inferiority immunogenicity studies. Other topics covered include fitting protection curves to data from vaccine efficacy studies, and the analysis of vaccine safety data. In addition, the book features four new chapters on vaccine field studies: an introductory one, one on randomized vaccine efficacy studies, one on observational vaccine effectiveness studies, and one on the meta-analysis of vaccine efficacy studies. The book offers useful insights for statisticians and epidemiologists working in the pharmaceutical industry or at vaccines institutes, as well as graduate students interested in pharmaceutical statistics. 410 0$aSpringer Series in Pharmaceutical Statistics,$x2366-8695 606 $aStatistics  606 $aVaccines 606 $aBiostatistics 606 $aPharmaceutical technology 606 $aImmunology 606 $aStatistics for Life Sciences, Medicine, Health Sciences$3https://scigraph.springernature.com/ontologies/product-market-codes/S17030 606 $aVaccine$3https://scigraph.springernature.com/ontologies/product-market-codes/B16010 606 $aBiostatistics$3https://scigraph.springernature.com/ontologies/product-market-codes/L15020 606 $aStatistical Theory and Methods$3https://scigraph.springernature.com/ontologies/product-market-codes/S11001 606 $aPharmaceutical Sciences/Technology$3https://scigraph.springernature.com/ontologies/product-market-codes/B21010 606 $aImmunology$3https://scigraph.springernature.com/ontologies/product-market-codes/B14000 615 0$aStatistics . 615 0$aVaccines. 615 0$aBiostatistics. 615 0$aPharmaceutical technology. 615 0$aImmunology. 615 14$aStatistics for Life Sciences, Medicine, Health Sciences. 615 24$aVaccine. 615 24$aBiostatistics. 615 24$aStatistical Theory and Methods. 615 24$aPharmaceutical Sciences/Technology. 615 24$aImmunology. 676 $a615.372 700 $aNauta$b Jozef$4aut$4http://id.loc.gov/vocabulary/relators/aut$01017960 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a996418271003316 996 $aStatistics in Clinical and Observational Vaccine Studies$92391157 997 $aUNISA