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020			_a9783030476823
024			_2doi _a10.1007/978-3-030-47682-3
040			_aES-MaUEC _bspa _dES-VaUE
050		4	_aRM301.27 _b.O53 2020 EB
245	1	0	_aPhase I Oncology Drug Development _cedited by Timothy A. Yap, Jordi Rodon, David S. Hong
250			_a1st ed. 2020
264		1	_aCham _bSpringer International Publishing _c2020
300			_a1 recurso en línea (I-X, 352 páginas) _bIlustraciones en color
336			_aTexto (visual) _btxt _2rdacontent
337			_aelectrónico _bc _2rdamedia
338			_arecurso electrónico _bcr _2rdacarrier
490			_aMedicine (Springer-11650)
505	0		_aThe Development of a Drug: A Pharmaceutical Drug Development Perspective Michael Lahn Pages 1-15 Paradigms in Cancer Drug Development: A Universe with Many Galaxies Cinta Hierro, Jordi Rodon Pages 17-44 Preclinical Studies to Enable First in Human Clinical Trials Rajesh Chopra, Florence I. Raynaud Pages 45-69 Practicalities of Setting Up a Phase I Clinical Trial Unit Within an Academic Center David S. Hong, Kathrina L. Marcelo-Lewis, Patricia LoRusso Pages 71-83 Novel Trial Designs for Early Phase Clinical Trials Chia-Chi Lin Pages 85-93 Examining Performance of Phase I Designs: 3+3 Versus Bayesian Optimal Interval (BOIN) Kenneth R. Hess, Bryan M. Fellman Pages 95-107 Considerations for the Attribution and Management of Toxicities in Phase I Clinical Trials Pedro C. Barata, David S. Hong Pages 109-118 Strategies for Incorporating Pharmacokinetic Studies into Oncology Phase I Trials Lingzhi Wang, Wan Qin Chong, Pei Shi Ong, Boon Cher Goh Pages 119-138 Development of Pharmacodynamic Biomarkers for Phase I Trials María Vieito, Itziar Gardeazabal, Ignacio Matos, Elena Garralda Pages 139-158 Efficacy Considerations in Phase I Trials Kanan Alshammari, Kirsty Taylor, Lillian L. Siu Pages 159-183 Considerations for the Development of Novel Chemotherapies and Antibody Drug Conjugates in Phase I Trials Vivek Subbiah, Roman Groisberg Pages 185-198 Development of Molecularly Targeted Agents in Early Phase Clinical Trials Pedro C. Barata, Timothy A. Yap Pages 199-220 Incorporating Precision Medicine into Phase I Clinical Trials Funda Meric-Bernstam Pages 221-231 Incorporating Circulating Biomarkers into Clinical Trials Filip Janku Pages 233-247 Development of Immunotherapeutic Strategies for Early Phase Clinical Trials Patricia Martin-Romano, Roman Chabanon, Adrien Procureur, Sandrine Aspeslagh, Sophie Postel-Vinay Pages 249-282 Radiotherapy Considerations and Strategic Approaches in Phase I Trials Lauren E. Colbert, Ying Yuan, Jaap D. Zindler, Clifton D. Fuller, Charles R. Thomas Pages 283-296 The Paradigm of Early Phase Studies in Hematological Malignancies Vishwanath Sathyanarayanan, Swaminathan P. Iyer Pages 297-311 Pharmacokinetic Considerations for Organ Dysfunction Clinical Trials in Early Drug Development Analia Azaro, Mehmet Esat Demirhan, Joann Lim, Jordi Rodon Pages 313-342
520			_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.
988	0	0	_aEBOOK
650		7	_aOncología _9139207 _2embne
700			_aYap, Timothy A. _9516317
700			_aRodon, Jordi _9516318
700			_aHong, David S. _9516319
710			_aSpringerLink _0Local _0http://id.loc.gov/authorities/names/no2005046756 _9106996
856	4	0	_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=http://dx.doi.org/10.1007/978-3-030-47682-3 _zAcceso a este recurso digital (usuarios Universidad Europea de Valencia)
901			_ai9783319390536
907			_a.b1295388x _b10-10-17 _c21-11-16
942			_2lcc _cLE
945			_aEBOOK EB _g1 _ieBOOK _j0 _lmae _o- _pEUR0.00 _q- _r- _sb _t15 _u0 _v0 _w0 _x0 _y.i11614948 _z30-06-17
998			_b10/2018 _db _feng _ggw _h0