LEADER 04750nam 2200613 450 001 9910420949303321 005 20220713170535.0 010 $a3-030-47682-0 024 7 $a10.1007/978-3-030-47682-3 035 $a(CKB)4100000011457856 035 $a(DE-He213)978-3-030-47682-3 035 $a(MiAaPQ)EBC6351809 035 $a(PPN)250222744 035 $a(EXLCZ)994100000011457856 100 $a20210216d2020 uy 0 101 0 $aeng 135 $aurnn#008mamaa 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aPhase I oncology drug development /$fTimothy A. Yap, Jordi Rodon, David S. Hong, editors 205 $a1st ed. 2020. 210 1$aCham, Switzerland :$cSpringer,$d[2020] 210 4$dİ2020 215 $a1 online resource (X, 352 pages, 47 illustration, 45 illustrations in color.) 311 $a3-030-47681-2 320 $aIncludes bibliographical references and index. 327 $aParadigm shift in oncology drug development -- Practicalities in setting up phase I trials -- Optimizing the preclinical development of antitumor agents for entry into phase I trials -- Considerations for the development of novel chemotherapies in phase I trials -- Considerations for the development of novel targeted agents in phase I trials -- Development of immunotherapeutic strategies in early phase clinical trials -- Assessment of radiotherapeutic strategies in phase I trials -- Development of combinatorial strategies in phase I trials -- Novel trial designs for early phase clinical trials -- Incorporating pharmacokinetic strategies for phase I trials -- Development of pharmacodynamic biomarkers for phase I trials -- Efficacy considerations for Phase I trials -- Incorporating precision medicine into Phase I clinical trials -- Molecular profiling of patients for clinical trials -- Incorporating circulating biomarkers into clinical trials -- Statistical considerations for early phase clinical trials -- Lessons from hematology for solid tumor drug development. . 330 $aThis book provides a detailed review of how oncology drug development has changed over the past decade, and serves as a comprehensive guide for the practicalities in setting up phase I trials. The book covers strategies to accelerate the development of novel antitumor compounds from the laboratory to clinical trials and beyond through the use of innovative mechanism-of-action pharmacodynamic biomarkers and pharmacokinetic studies. The reader will learn about all aspects of modern phase I trial designs, including the incorporation of precision medicine strategies, and approaches for rational patient allocation to novel anticancer therapies. Circulating biomarkers to assess mechanisms of response and resistance are changing the way we are assessing patient selection and are also covered in this book. The development of the different classes of antitumor agents are discussed, including chemotherapy, molecularly targeted agents, immunotherapies and also radiotherapy. The authors also discuss the lessons that the oncology field has learnt from the development of hematology-oncology drugs and how such strategies can be carried over into therapies for solid tumors. There is a dedicated chapter that covers the specialized statistical approaches necessary for phase I trial designs, including novel Bayesian strategies for dose escalation. This volume is designed to help clinicians better understand phase I clinical trials, but would also be of use to translational researchers (MDs and PhDs), and drug developers from academia and industry interested in cancer drug development. It could also be of use to phase I trial study coordinators, oncology nurses and advanced practice providers. Other health professionals interested in the treatment of cancer will also find this book of great value. . 606 $aAntineoplastic agents$xDesign 606 $aCancer$xChemotherapy 606 $aDrug development 606 $aAntineoplastic Agents 606 $aDrug Development 606 $aNeoplasms$xdrug therapy 606 $aClinical Trials, Phase I as Topic 615 0$aAntineoplastic agents$xDesign. 615 0$aCancer$xChemotherapy. 615 0$aDrug development. 615 2$aAntineoplastic Agents. 615 2$aDrug Development. 615 2$aNeoplasms$xdrug therapy. 615 2$aClinical Trials, Phase I as Topic. 676 $a616.994061 702 $aYap$b Timothy A. 702 $aHong$b David S. 702 $aRodon$b Jordi 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910420949303321 996 $aPhase I oncology drug development$92034074 997 $aUNINA LEADER 02028nam 2200421 450 001 9910795161103321 005 20230807203322.0 010 $a3-8325-9144-3 035 $a(CKB)4910000000017352 035 $a(MiAaPQ)EBC5850433 035 $a5a8e86f4-67f8-47a2-8e2b-66c5b0dd2d03 035 $a(EXLCZ)994910000000017352 100 $a20190917d2015 uy 0 101 0 $aeng 135 $aurcnu|||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aD-modules $elocal formal convolution of elementary formal meromorphic connections /$fRobert Gelb 210 1$aBerlin :$cLogos Verlag,$d[2015] 210 4$dİ2015 215 $a1 online resource (98 pages) 225 0 $aAugsburger Schriften zur Mathematik, Physik und Informatik ;$v27 300 $aPublicationDate: 20150228 311 $a3-8325-3894-1 320 $aIncludes bibliographical references. 330 $aLong description: According to the classical theorem of Levelt-Turrittin-Malgrange and its refined version, developed by Claude Sabbah, any meromorphic connection over the field of formal Laurent series in one variable can be decomposed in a direct sum of so called elementary formal meromorphic connections. Changing the perspective, one can also study operations that can be carried out with such special differential modules. There are already formulas for the tensor product or the local formal Fourier transform, for example. This thesis analyses the local formal convolution (the multiplicative case as well as the additive case) of two elementary formal meromorphic connections and how the convolution can itself be decomposed into a direct sum of elementary formal meromorphic connections again. 606 $aD-modules 615 0$aD-modules. 676 $a512.4 700 $aGelb$b Robert$01467563 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910795161103321 996 $aD-modules$93678246 997 $aUNINA