The Resource Appropriate Dose Selection - How to Optimize Clinical Drug Development, edited by J. Venitz, W. Sittner, (electronic resource)

Appropriate Dose Selection - How to Optimize Clinical Drug Development, edited by J. Venitz, W. Sittner, (electronic resource)

Label
Appropriate Dose Selection - How to Optimize Clinical Drug Development
Title
Appropriate Dose Selection - How to Optimize Clinical Drug Development
Statement of responsibility
edited by J. Venitz, W. Sittner
Contributor
Editor
Editor
Subject
Language
  • eng
  • eng
Summary
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
Member of
Is Subseries of
Dewey number
615/.19
http://bibfra.me/vocab/relation/httpidlocgovvocabularyrelatorsedt
  • 24zrJL1rPj4
  • lcz4RVYsJF8
Language note
English
LC call number
RM1-950
Literary form
non fiction
Nature of contents
dictionaries
http://library.link/vocab/relatedWorkOrContributorName
  • Venitz, J.
  • Sittner, W.
Series statement
Ernst Schering Foundation Symposium Proceedings,
Series volume
59
http://library.link/vocab/subjectName
  • Toxicology
  • Medicine
  • Biochemistry
  • Pharmacology/Toxicology
  • Medicine/Public Health, general
  • Biochemistry, general
Label
Appropriate Dose Selection - How to Optimize Clinical Drug Development, edited by J. Venitz, W. Sittner, (electronic resource)
Instantiates
Publication
Note
Description based upon print version of record
Bibliography note
Includes bibliographical references
Carrier category
online resource
Carrier category code
cr
Content category
text
Content type code
txt
Contents
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
Dimensions
unknown
Edition
1st ed. 2007.
Extent
1 online resource (236 p.)
Form of item
online
Isbn
9781280804502
Media category
computer
Media type code
c
Other control number
10.1007/978-3-540-49529-1
Specific material designation
remote
System control number
  • (CKB)1000000000284496
  • (EBL)371403
  • (OCoLC)184984558
  • (SSID)ssj0000104926
  • (PQKBManifestationID)11122028
  • (PQKBTitleCode)TC0000104926
  • (PQKBWorkID)10087405
  • (PQKB)10924261
  • (DE-He213)978-3-540-49529-1
  • (MiAaPQ)EBC371403
  • (EXLCZ)991000000000284496
Label
Appropriate Dose Selection - How to Optimize Clinical Drug Development, edited by J. Venitz, W. Sittner, (electronic resource)
Publication
Note
Description based upon print version of record
Bibliography note
Includes bibliographical references
Carrier category
online resource
Carrier category code
cr
Content category
text
Content type code
txt
Contents
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
Dimensions
unknown
Edition
1st ed. 2007.
Extent
1 online resource (236 p.)
Form of item
online
Isbn
9781280804502
Media category
computer
Media type code
c
Other control number
10.1007/978-3-540-49529-1
Specific material designation
remote
System control number
  • (CKB)1000000000284496
  • (EBL)371403
  • (OCoLC)184984558
  • (SSID)ssj0000104926
  • (PQKBManifestationID)11122028
  • (PQKBTitleCode)TC0000104926
  • (PQKBWorkID)10087405
  • (PQKB)10924261
  • (DE-He213)978-3-540-49529-1
  • (MiAaPQ)EBC371403
  • (EXLCZ)991000000000284496

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