Descripción del título
Appropriate dose selection ...
Optimal dose individualization has become more important in improving clinical efficacy and safety, given the variability in drug response, e.g., due to concurrent illnesses or co-medications. Therefore, the role of optimal dose finding in early clinical drug development so as to maximize successful clinical use is emphasized. The continued use of biomarkers -- based on the (known) pharmacology of the drug and/or biology of the underlying disease -- along with exposure--response evaluation throughout all phases of drug development can quantitatively integrate clinical pharmacology knowledge, provide early proof of concept, and help in rational dose selection and rational drug product labeling for clinical use
Monografía
monografia Rebiun25210632 https://catalogo.rebiun.org/rebiun/record/Rebiun25210632 m o d cr cn||||||||| 071221s2007 gw a ob 100 0 eng d 156526965 228376586 320971728 607531825 613446800 648134672 698453983 756425972 880114279 987702151 994829944 1005766538 1056371247 1056377714 1066601355 1078022221 1086909037 1086941920 1097278953 1097302882 1105601900 1110902493 1110948112 1112583065 1125444600 1136459953 9783540495291 3540495290 3540278672 Cloth) 9783540278672 Cloth) 9786610804504 6610804508 10.1007/978-3-540-49529-1 doi AU@ 000043265335 DEBSZ 442811942 NZ1 11677230 978-3-540-27867-2 Springer http://www.springerlink.com GW5XE eng pn GW5XE GW5XE YDXCP TEX OCLCQ EBLCP OCLCQ N$T CEF UAB CNTRU UBF E7B MNU IDEBK OCLCO OCLCQ A7U OCLCQ BEDGE OCLCQ SLY COO DEBSZ OCLCQ TXI OCLCQ LVT OCLCO Z5A OTZ OCLCQ ESU OCLCQ MERER VT2 OCLCO OCLCA OCLCF U3W OCLCQ WYU AU@ OCLCA ICG OCLCQ OCLCO YOU CANPU W2U NZHMA OCLCO OCLCQ OCLCO AUD ZHM DCT ERF WURST OCLCQ SFB OCLCA RM lcco MED 023000 bisacsh MED 071000 bisacsh MED 072000 bisacsh MED 058170 bisacsh MMG bicssc 615/.19 22 R730. 53 clc Appropriate dose selection how to optimize clinical drug development J. Venitz, W. Sittner, editors Berlin Springer 2007 Berlin Berlin Springer 1 online resource (xvi, 216 pages) illustrations (some color) 1 online resource (xvi, 216 pages) Text txt rdacontent computer c rdamedia online resource cr rdacarrier text file PDF rda Ernst Schering Research Foundation workshop 0947-6075 59 Includes bibliographical references Extrapolation of Preclinical Data into Clinical Reality -- Translational Science -- Smarter Candidate Selection -- Utilizing Microdosing in Exploratory Clinical Studies -- The Applications of Biomarkers in Early Clinical Drug Development to Improve Decision-Making Processes -- Using Exposure -- Response and Biomarkers to Streamline Early Drug Development -- Experiences with Dose Finding in Patients in Early Drug Development: The Use of Biomarkers in Early Decision Making -- Genotype and Phenotype Relationship in Drug Metabolism -- Clinical Trials in Elderly Patients -- Dose Finding in Pediatric Patients -- Integration of Pediatric Aspects into the General Drug Development Process -- Current Stumbling Blocks in Oncology Drug Development -- Exploratory IND: A New Regulatory Strategy for Early Clinical Drug Development in the United States -- Ethnic Aspects of Cancer Trials in Asia -- Evaluation of the Effect on Cardiac Repolarization (QTc Interval) of Oncologic Drugs -- The Role of PET Scanning in Determining Pharmacoselective Doses in Oncology Drug Development -- Biometrical Aspects of Drug Development -- Preventing Postmarketing Changes in Recommended Doses and Marketing Withdrawals Optimal dose individualization has become more important in improving clinical efficacy and safety, given the variability in drug response, e.g., due to concurrent illnesses or co-medications. Therefore, the role of optimal dose finding in early clinical drug development so as to maximize successful clinical use is emphasized. The continued use of biomarkers -- based on the (known) pharmacology of the drug and/or biology of the underlying disease -- along with exposure--response evaluation throughout all phases of drug development can quantitatively integrate clinical pharmacology knowledge, provide early proof of concept, and help in rational dose selection and rational drug product labeling for clinical use Drugs- Dose-response relationship Cáncer- Drug testing Drug development Neoplasms- drug therapy Drug Evaluation Drug Interactions MEDICAL- Drug Guides MEDICAL- Pharmacology MEDICAL- Pharmacy MEDICAL- Nursing- Pharmacology Drug evaluation Drug interactions Drugs- Dose-response relationship Cáncer- Drug testing Drug development Neoplasms- drug therapy Biomédecine Sciences de la vie Drug development Drugs- Dose-response relationship biochemie biochemistry geneeskunde medicine volksgezondheid public health farmacologie pharmacology toxicologie toxicology biomedische wetenschappen biomedicine Medicine (General) Geneeskunde (algemeen) Congress Electronic books Venitz, J. Jürgen) Sittner, W. Wolf) Springer e-books Springer e-books Print version Appropriate dose selection. Berlin : Springer, 2007 9783540278672 3540278672 (DLC) 2006928310 (OCoLC)75231130 Ernst Schering Research Foundation workshop 59. 0947-6075