LEADER 05260nam 2200661 a 450 001 9910781962303321 005 20200520144314.0 010 $a1-283-32021-5 010 $a9786613320216 010 $a0-12-391913-4 035 $a(CKB)2550000000062029 035 $a(EBL)802460 035 $a(OCoLC)763157847 035 $a(SSID)ssj0000589375 035 $a(PQKBManifestationID)12290823 035 $a(PQKBTitleCode)TC0000589375 035 $a(PQKBWorkID)10656639 035 $a(PQKB)10049457 035 $a(Au-PeEL)EBL802460 035 $a(CaPaEBR)ebr10509955 035 $a(MiAaPQ)EBC802460 035 $a(PPN)190226498 035 $a(EXLCZ)992550000000062029 100 $a20111119d2012 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aClinical trials$b[electronic resource] $estudy design, endpoints and biomarkers, drug safety, FDA and ICH guidelines /$fTom Brody 205 $a1st ed. 210 $aLondon $cAcademic Press$d2012 215 $a1 online resource (673 p.) 300 $aDescription based upon print version of record. 311 $a0-12-391911-8 320 $aIncludes bibliographical references and index. 327 $aFront Cover; Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, FDA and ICH Guidelines; Copyright Page; Contents; Acknowledgments; Preface; The Study Schema and Study Design; Intent to Treat Analysis; How to Choose the Endpoints; Diagnostic Tests; Mechanism of Action; Standards; Methodology; Clinicaltrials.Gov and other Registries for Clinical Trials; Introduction; Abbreviations and Definitions; Biography; 1 The Origins of Drugs; I. Introduction; II. Structures of Drugs; a. Origins of warfarin; b. Origins of methotrexate and 5-fluorouracil; c. Origins of ribavirin 327 $ad. Origins of paclitaxele. Origins of cladribine; f. Origins of drugs in high-throughput screening; g. Origins of therapeutic antibodies; III. The 20 Classical Amino Acids; IV. Animal Models; a. Introduction; b. Estimating human dose from animal studies; 1. NOAEL approach; 2. MABEL approach; c. Scaling up the drug dose, acquired from animal studies, for use in humans; 2 Introduction to Regulated Clinical Trials; I. Introduction; II. Study Design; III. The Study Schema; a. Examples of schema from clinical trials; b. Sequential treatment versus concurrent treatment - the Perez schema 327 $ac. Neoadjuvant chemotherapy versus adjuvant chemotherapy - the Gianni schemad. Neoadjuvant chemotherapy plus adjuvant chemotherapy - the Untch schema; e. Forwards sequence and reverse sequence - the Puhalla schema; f. Both arms received three drugs, each arm at a different schedule - the Sekine schema; g. Staging - the Blumenschein schema; h. Staging and restaging - the Czito schema; i. Methodology tip - staging; j. Decision tree - the Baselga schema; k. Decision tree - the Katsumata schema; l. Methodology tip - what is "tumor progression"? 327 $am. Methodology tip - unit of drug dose expressed in terms of body surface arean. Run-in period - the schema of Dy; o. Methodology tip - c-kit and imatinib; p. Run-in period - the Hanna schema; q. How to maintain blinding of the treatment, when the study drug and the control treatment are provided by different-sized pills (or by different volumes of solutions)...; r. Methodology tip - bevacizumab and VEGF; s. Dose escalation - the Moore schema; t. Pharmacokinetics - the Marshall schema; IV. Further Concepts In Study Design; a. Active control; b. Add-on design active control 327 $ac. Three-arm study - clinical trial with two different active control armsV. Summary; VI. Amendments to the Clinical Study Protocol; 3 Run-In Period; I. Introduction; a. Washout period; b. Detecting baseline adverse events; c. Excluding potential study subjects who have safety issues correlating with the study drug; d. To include only study subjects with controllable pain; e. To determine the maximal tolerable dose; f. To achieve and ensure steady state in vivo concentrations of study drug 327 $ag. To allow a period of adjustment of lifestyle of the study subjects, for example changes in dietary patterns 330 $aClinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts. It provides extensive information on both US and international regulatory guidelines and features concrete examples of study design from the medical literature. This book is intended to orient those new to clinical trial design and provide them with a better u 606 $aClinical trials 606 $aDrugs$xTesting 615 0$aClinical trials. 615 0$aDrugs$xTesting. 676 $a615.19 676 $a615.50724 676 $a615/.19 700 $aBrody$b Tom$0481636 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910781962303321 996 $aClinical trials$93761535 997 $aUNINA LEADER 07799nam 22007815 450 001 9910484763303321 005 20250609110942.0 010 $a9783319154190 010 $a3319154192 024 7 $a10.1007/978-3-319-15419-0 035 $a(CKB)3710000000377965 035 $a(EBL)2094380 035 $a(SSID)ssj0001465369 035 $a(PQKBManifestationID)11821040 035 $a(PQKBTitleCode)TC0001465369 035 $a(PQKBWorkID)11471678 035 $a(PQKB)10190479 035 $a(DE-He213)978-3-319-15419-0 035 $a(MiAaPQ)EBC2094380 035 $a(PPN)184889456 035 $a(MiAaPQ)EBC3108610 035 $a(EXLCZ)993710000000377965 100 $a20150316d2015 u| 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aAs the Witnesses Fall Silent: 21st Century Holocaust Education in Curriculum, Policy and Practice /$fedited by Zehavit Gross, E. Doyle Stevick 205 $a1st ed. 2015. 210 1$aCham :$cSpringer International Publishing :$cImprint: Springer,$d2015. 215 $a1 online resource (507 p.) 300 $aDescription based upon print version of record. 311 08$a9783319154183 311 08$a3319154184 320 $aIncludes bibliographical references at the end of each chapters. 327 $aPreface: Mmantsetsa Marope, Director, UNESCO IBE -- Editors? notes and acknowledgements -- Part I: Introduction -- Holocaust education in the 21st century: Curriculum, policy and practice.  E. Doyle Stevick and Zehavit Gross -- Part II: Framing the issues for a new millennium -- Address to the German Bundestag, 27 January 2000. Elie Wiesel -- ?Why does the way of the wicked prosper?? Teaching the Holocaust in the land of Jim Crow: Ted Rosengarten -- Is teaching and learning about the Holocaust relevant for human rights education? Monique Eckmann -- Shoah, antisemitism, war and genocide: Text and context. Yehuda Bauer -- Learning from eyewitnesses: Examining the history and future of personal encounters with Holocaust survivors and resistance fighters. Dienke Hondius -- Teaching about and teaching through the Holocaust: Insights from (social) psychology. Barry van Driel -- Part III Reckoning with the Holocaust in Israel, Germany and Poland -- Between involuntary and voluntary memories: A case study of Holocaust education in Israel. Zehavit Gross -- Domesticating the difficult past: Polish students narrate the Second World War. Magdalena Gross.-  Mind the gap: Holocaust education in Germany, between pedagogical intentions and classroom interactions. Wolfgang Meseth and Matthias Proske -- Part IV  Holocaust education in diverse classrooms -- Holocaust education and critical citizenship in an American fifth grade: Expanding repertoires of meanings, language and action. Louise B. Jennings -- ?They think it is funny to call us Nazis?: Holocaust education and multicultural education in a diverse Germany. Debora Hinderliter Ortloff -- Genocide or Holocaust education: Exploring different Australian approaches for Muslim school children. Suzanne D. Rutland -- Part V: International dynamics, global trends and comparative research in Holocaust education. A global mapping of the Holocaust in textbooks and curricula. Peter Carrier, Eckhardt Fuchs, and TorbenMessinger -- International organisations in the globalisation of Holocaust education. Karel Fracapane -- Compliant policy and multiple meanings: Conflicting Holocaust discourses in Estonia. E. Doyle Stevick -- The Holocaust as history and human rights: A cross-national analysis of Holocaust education in social science textbooks, 1970?2008. Patricia Bromley and Susan Garnett Russell -- Measuring Holocaust knowledge and its relationship to attitudes towards diversity in Spain, Canada, Germany and the United States. Jack Jedwab -- Part VI  Holocaust education in national and regional contexts -- Holocaust history, memory and citizenship education: The case of Latvia. Tom Misco -- Mastering the past? Nazism and the Holocaust in West German history textbooks of the 1960s. Brian Puaca -- Informed pedagogy on the Holocaust: A survey of educators trained by leading Holocaust organizations in the United States. Corey Harbaugh -- "Unless they have to": Power, politics and institutional hierarchy in Lithuanian Holocaust education. Christine Beresniova --  Holocaust education in Austria: A (hi)story of complexity and prospects for the future. Herbert Bastel, Christian Matzka, and Helene Miklas -- ?Thanks to Scandinavia? and beyond: Nordic Holocaust education in the 21st century. Fred Dervin.-  Holocaust education in Scotland: Taking the lead or falling behind? Paula Cowan and Henry Maitles -- Part VII To know, to remember, to act -- Failing to learn from the Holocaust. Geoffrey Short -- Towards a new theory of Holocaust remembrance in Germany: Education, preventing antisemitism and advancing human rights. Reinhold Boschki, Bettina Reichmann, and Wilhelm Schwendemann -- Epistemological aspects of Holocaust education: Between ideologies and  interpretations. Zehavit Gross and Doyle Stevick -- Notes on contributors.  . 330 $aThis volume represents the most comprehensive collection ever produced of empirical research on Holocaust education around the world. It comes at a critical time, as the world approaches the 70th anniversary of the liberation of Auschwitz. We are now at a turning point as the generations that witnessed and survived the Shoah are slowly passing on. Governments are charged with ensuring that this defining event of the 20th century should take its rightful place in the historical consciousness of the world's peoples and their education. The policies and practices of Holocaust education around the world are as diverse as the countries that grapple with its history and its meaning.The effort to reconcile national histories and memories with the international realities of the Holocaust and its implications for the present persists. These efforts take place at a time when scholarship about the Holocaust itself has made great strides. In this book, these issues are framed by some of the leading voices in the field, including Elie Wiesel and Yehuda Bauer, and then explored by many distinguished scholars who represent a wide range of expertise. Holocaust education is of such significance, so rich in meaning, so powerful in content, and so diverse in practice that the need for extensive, high-quality empirical research is critical. This book provides exactly that.    . 606 $aInternational education 606 $aComparative education 606 $aEducational sociology 606 $aEducation and state 606 $aEducation$xCurricula 606 $aInternational and Comparative Education 606 $aSociology of Education 606 $aEducational Policy and Politics 606 $aCurriculum Studies 615 0$aInternational education. 615 0$aComparative education. 615 0$aEducational sociology. 615 0$aEducation and state. 615 0$aEducation$xCurricula. 615 14$aInternational and Comparative Education. 615 24$aSociology of Education. 615 24$aEducational Policy and Politics. 615 24$aCurriculum Studies. 676 $a306.43 676 $a370 676 $a370.116 676 $a370.9 676 $a375 676 $a379 702 $aGross$b Zehavit$4edt$4http://id.loc.gov/vocabulary/relators/edt 702 $aStevick$b E. Doyle$4edt$4http://id.loc.gov/vocabulary/relators/edt 906 $aBOOK 912 $a9910484763303321 996 $aAs the Witnesses Fall Silent: 21st Century Holocaust Education in Curriculum, Policy and Practice$92852062 997 $aUNINA