Med bibl SkaS

*00000000cam a2200000Ki 4500
*00182909
*00520200616072747.6
*006m     o  d
*007cr cnu---unuuu
*008160322s2016    enk     ob    001 0 eng d
*019  $a951033138$a956735896
*020  $a9780128042588
*020  $a0128042583
*020  $z9780128042175
*020  $z0128042176
*029  $aAU@$b000058943157
*029  $aGBVCP$b858562367
*035  $a(OCoLC)945375877$z(OCoLC)951033138$z(OCoLC)956735896
*035  $a(OCoLC)ocn945375877
*040  $aOPELS$beng$erda$epn$cOPELS$dUIU$dOCLCF$dGGVRL$dTMC$dOCLCO$dUIU$dMERER$dOCLCO$dOCLCQ$dLEATE$dU3W$dOCLCA$dBUF$dOCLCO$dD6H$dUUM$dAU@$dOCLCQ
*049  $aMAIN
*050 4$aR853.C55
*060 4$aQV 771.4$bB864c
*08204$a615.50724$223
*1001 $aBrody, Tom,$eauthor.
*24510$aClinical trials :$bstudy design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines /$cTom Brody, Ph. D.
*250  $aSecond edition.
*264 1$aLondon :$bAcademic Press is an imprint of Elsevier,$c2016.
*300  $a1 online resource
*336  $atext$btxt$2rdacontent
*337  $acomputer$bc$2rdamedia
*338  $aonline resource$bcr$2rdacarrier
*500  $aIncludes index.
*504  $aIncludes bibliographical references and index.
*5050 $a1. Origins of drugs -- 2. Clinical trial design -- 3. Run-in period -- 4. Inclusion/exclusion criteria, stratification, and subgroups -- part I -- 5. Inclusion/exclusion criteria, stratification, and subgroups -- part II -- 6. Blinding, randomization, and allocation -- 7. Placebo arm as part of clinical trial design -- 8. Intent-to-treat analysis versus per protocol analysis -- 9. Biostatistics -- part I -- 10. Biostatistics -- part II -- 11. Introduction to endpoints -- 12. Oncology endpoint -- objective response -- 13. Oncology endpoints : overall survival and progression-free survival -- 14. Oncology endpoints : time to progression -- 15. Oncology endpoint : disease-free survival -- 16. Oncology endpoint : time to distant metastasis -- 17. Neoadjuvant therapy versus adjuvant therapy -- 18. Hematological cancers -- 19. Biomarkers -- 20. Endpoints for immune diseases -- 21. Endpoints for infections -- 22. Health-related quality of life tools -- oncology -- 23. Health-related quality-of-life tools -- immune disorders -- 24. Health-related quality-of-life tools -- infections -- 25. Drug safety -- 26. Mechanism of action of diseases and drugs -- part I -- 27. Mechanism of action -- part II (cancer) -- 28. Mechanism of action -- part III (immune disorders) -- 29. Mechanisms of action -- part IV (infections) -- 30. Consent forms -- 31. Package inserts -- 32. Warning letters -- 33. Regulatory approval -- 34. Patents.
*520  $aClinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials.
*5880 $aOnline resource; title from PDF title page (ScienceDirect, viewed March 22, 2016).
*590  $aElsevier$bElsevier ClinicalKey eBooks
*590  $aElsevier$bElsevier ClinicalKey
*650 0$aClinical trials$xDesign.
*650 7$aClinical trials$xDesign.$2fast$0(OCoLC)fst00864431
*65022$aClinical Trials as Topic.$0https://id.nlm.nih.gov/mesh/D002986
*65022$aDrug Approval.
*65022$aResearch Design.
*65022$aClinical Trials Data Monitoring Committees.
*655 4$aElectronic books.
*77608$iPrint version:$aBrody, Tom.$tClinical Trials : Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines.$dSaint Louis : Elsevier Science, ©2016$z9780128042175
*85640$uhttps://www.clinicalkey.com/dura/browse/bookChapter/3-s2.0-C20150013557
*938  $aGale Cengage Learning$bGVRL$nGVRL9JSX
*994  $a92$bSESKS
^