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Dose finding in drug develo...
"Dosing information on the drug label is based on discussion and agreement between the pharmaceutical manufacturer and the drug regulatory agency. A drug label is a high level summary of results obtained from many scientific experiments. Scientists with biological, chemical, medical, or statistical background working in the pharmaceutical industry designed and executed these experiments to obtain information to help understand the dosing information." "This book introduces the drug development process, the design and analysis of clinical trials. Many of the discussions are based on applications of statistical methods in the design and analysis of dose response studies. Although the book is prepared mainly for statisticians/biostatisticians, it also serves as a useful reference to a variety of professionals working for the pharmaceutical industry. The potential readers include pharmacokienticists, clinical scientists, clinical pharmacologists, pharmacists, project managers, pharmaceutical scientists, clinicians, programmers, data managers, regulatory specialists, and study report writers. This book is also a good reference for professionals working in a drug regulatory environment, for example, the FDA. Scientists and/or reviewers from both U.S. and foreign drug regulatory agencies can benefit greatly from this book. In addition, statistical and medical professionals in academia may find this book helpful in understanding the drug development process and practical concerns in selecting doses for a new drug."--Jacket
Monografía
monografia Rebiun25351906 https://catalogo.rebiun.org/rebiun/record/Rebiun25351906 m o d cr |n||||||||| 051006s2006 nyua ob 001 0 eng c 2005935288 154695927 209914880 213887155 228150138 228150139 228398254 607298008 647650350 698452554 756421643 880096169 990548255 994843805 1005762791 1024276737 1035658997 1044147973 1044215856 1044250944 1056326623 1056348364 1056384413 1060685871 1060781345 1069379441 1077271000 1086806304 1136177916 9780387290744 0387290745 9780387337067 electronic bk.) 0387337067 electronic bk.) 6610726647 9786610726646 10.1007/0-387-33706-7 doi AU@ 000042135331 DEBSZ 264336658 DEBSZ 442810431 DKDLA 820120-katalog:000661889 HEBIS 192022873 NLGGC 384205941 NZ1 12050803 978-0-387-29074-4 Springer http://www.springerlink.com COO eng pn COO N$T YDXCP GW5XE UAB DKU OCLCQ CEF OCLCQ COA OCLCQ YNG E7B UBC MHW IDEBK OCLCO OCLCQ A7U OCLCQ SLY OCLCQ DEBSZ EBLCP OCLCQ LVT Z5A LIP OTZ OCLCQ OCLCO ESU OCLCQ VT2 OCLCF STF OCLCQ U3W OCLCQ WYU OCLCO OCLCA ICG OCLCO UWO YOU CANPU OCLCA OCLCQ W2U OCLCO AUD OCLCO OCLCQ OCLCA CNTRU DCT SFB OCLCA pcc MED 023000 bisacsh MED 071000 bisacsh MED 072000 bisacsh MED 058170 bisacsh 615/.19 22 R914 clc Dose finding in drug development Naitee Ting, editor New York, NY Springer 2006 New York, NY New York, NY Springer 1 online resource (xiv, 248 pages) illustrations 1 online resource (xiv, 248 pages) Text txt rdacontent computer c rdamedia online resource cr rdacarrier Statistics for biology and health Includes bibliographical references Front Matter; Introduction and New Drug Development Process; Dose Finding Based on Preclinical Studies; Dose-Finding Studies in Phase I and Estimation of Maximally Tolerated Dose; Dose-Finding in Oncology -- Nonparametric Methods; Dose Finding in Oncology -- Parametric Methods; Dose Response: Pharmacokinetic-Pharmacodynamic Approach; General Considerations in Dose-Response Study Designs; Clinical Trial Simulation -- A Case Study Incorporating Efficacy and Tolerability Dose Response; Analysis of Dose-Response Studies -- Emax Model; Analysis of Dose-Response Studies -- Modeling Approaches "Dosing information on the drug label is based on discussion and agreement between the pharmaceutical manufacturer and the drug regulatory agency. A drug label is a high level summary of results obtained from many scientific experiments. Scientists with biological, chemical, medical, or statistical background working in the pharmaceutical industry designed and executed these experiments to obtain information to help understand the dosing information." "This book introduces the drug development process, the design and analysis of clinical trials. Many of the discussions are based on applications of statistical methods in the design and analysis of dose response studies. Although the book is prepared mainly for statisticians/biostatisticians, it also serves as a useful reference to a variety of professionals working for the pharmaceutical industry. The potential readers include pharmacokienticists, clinical scientists, clinical pharmacologists, pharmacists, project managers, pharmaceutical scientists, clinicians, programmers, data managers, regulatory specialists, and study report writers. This book is also a good reference for professionals working in a drug regulatory environment, for example, the FDA. Scientists and/or reviewers from both U.S. and foreign drug regulatory agencies can benefit greatly from this book. In addition, statistical and medical professionals in academia may find this book helpful in understanding the drug development process and practical concerns in selecting doses for a new drug."--Jacket Drugs- Dose-response relationship- Mathematics Drug development Dose-Response Relationship, Drug Drug Compounding MEDICAL- Drug Guides MEDICAL- Pharmacology MEDICAL- Pharmacy MEDICAL- Nursing- Pharmacology Drug development Dose-response relationship, Drug Drug Compounding Drugs- Dose-response relationship- Mathematics Drug development Electronic books Ting, Naitee Springer e-books Springer e-books Print version Dose finding in drug development. New York, NY : Springer, 2006 9780387290744 0387290745 (DLC) 2005935288 (OCoLC)67360779 Statistics for biology and health