04176nam 22006855 450 991048503070332120200701090609.03-030-37693-110.1007/978-3-030-37693-2(CKB)4100000010661139(DE-He213)978-3-030-37693-2(MiAaPQ)EBC6134238(PPN)243227558(EXLCZ)99410000001066113920200314d2020 u| 0engurnn#008mamaatxtrdacontentcrdamediacrrdacarrierStatistics in Clinical and Observational Vaccine Studies /by Jozef Nauta2nd ed. 2020.Cham :Springer International Publishing :Imprint: Springer,2020.1 online resourceSpringer Series in Pharmaceutical Statistics,2366-86953-030-37692-3 1.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.This 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.Springer Series in Pharmaceutical Statistics,2366-8695Statistics VaccinesBiostatisticsPharmaceutical technologyImmunologyStatistics for Life Sciences, Medicine, Health Scienceshttps://scigraph.springernature.com/ontologies/product-market-codes/S17030Vaccinehttps://scigraph.springernature.com/ontologies/product-market-codes/B16010Biostatisticshttps://scigraph.springernature.com/ontologies/product-market-codes/L15020Statistical Theory and Methodshttps://scigraph.springernature.com/ontologies/product-market-codes/S11001Pharmaceutical Sciences/Technologyhttps://scigraph.springernature.com/ontologies/product-market-codes/B21010Immunologyhttps://scigraph.springernature.com/ontologies/product-market-codes/B14000Statistics .Vaccines.Biostatistics.Pharmaceutical technology.Immunology.Statistics for Life Sciences, Medicine, Health Sciences.Vaccine.Biostatistics.Statistical Theory and Methods.Pharmaceutical Sciences/Technology.Immunology.615.372Nauta Jozefauthttp://id.loc.gov/vocabulary/relators/aut1017960MiAaPQMiAaPQMiAaPQBOOK9910485030703321Statistics in Clinical and Observational Vaccine Studies2391157UNINA