000 03559nam a22004815i 4500
001 978-3-540-49529-1
003 DE-He213
005 20161121230806.0
007 cr nn 008mamaa
008 100301s2007 gw | s |||| 0|eng d
020 _a9783540495291
_9978-3-540-49529-1
024 7 _a10.1007/978-3-540-49529-1
_2doi
050 4 _aRM1-950
072 7 _aMMG
_2bicssc
072 7 _aMED071000
_2bisacsh
082 0 4 _a615
_223
245 1 0 _aAppropriate Dose Selection — How to Optimize Clinical Drug Development
_h[electronic resource] /
_cedited by J. Venitz, W. Sittner.
264 1 _aBerlin, Heidelberg :
_bSpringer Berlin Heidelberg,
_c2007.
300 _aXVI, 216 p.
_bonline resource.
336 _atext
_btxt
_2rdacontent
337 _acomputer
_bc
_2rdamedia
338 _aonline resource
_bcr
_2rdacarrier
347 _atext file
_bPDF
_2rda
490 1 _aErnst Schering Research Foundation Workshop,
_x0947-6075 ;
_v59
505 0 _aExtrapolation 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.
520 _aOptimal 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.
650 0 _aMedicine.
650 0 _aPharmacology.
650 0 _aBiochemistry.
650 1 4 _aBiomedicine.
650 2 4 _aPharmacology/Toxicology.
650 2 4 _aMedicine/Public Health, general.
650 2 4 _aBiochemistry, general.
700 1 _aVenitz, J.
_eeditor.
700 1 _aSittner, W.
_eeditor.
710 2 _aSpringerLink (Online service)
773 0 _tSpringer eBooks
776 0 8 _iPrinted edition:
_z9783540278672
830 0 _aErnst Schering Research Foundation Workshop,
_x0947-6075 ;
_v59
856 4 0 _uhttp://dx.doi.org/10.1007/978-3-540-49529-1
912 _aZDB-2-SBL
950 _aBiomedical and Life Sciences (Springer-11642)
999 _c504027
_d504027