| 000 -LEADER |
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| fixed length control field |
03559nam a22004815i 4500 |
| 001 - CONTROL NUMBER |
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| control field |
978-3-540-49529-1 |
| 003 - CONTROL NUMBER IDENTIFIER |
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| control field |
DE-He213 |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
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| control field |
20161121230806.0 |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION |
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| fixed length control field |
cr nn 008mamaa |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
100301s2007 gw | s |||| 0|eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
9783540495291 |
| -- |
978-3-540-49529-1 |
| 024 7# - OTHER STANDARD IDENTIFIER |
|---|
| Standard number or code |
10.1007/978-3-540-49529-1 |
| Source of number or code |
doi |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER |
|---|
| Classification number |
RM1-950 |
| 072 #7 - SUBJECT CATEGORY CODE |
|---|
| Subject category code |
MMG |
| Source |
bicssc |
| 072 #7 - SUBJECT CATEGORY CODE |
|---|
| Subject category code |
MED071000 |
| Source |
bisacsh |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER |
|---|
| Classification number |
615 |
| Edition number |
23 |
| 245 10 - TITLE STATEMENT |
|---|
| Title |
Appropriate Dose Selection — How to Optimize Clinical Drug Development |
| Medium |
[electronic resource] / |
| Statement of responsibility, etc. |
edited by J. Venitz, W. Sittner. |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE |
|---|
| Place of production, publication, distribution, manufacture |
Berlin, Heidelberg : |
| Name of producer, publisher, distributor, manufacturer |
Springer Berlin Heidelberg, |
| Date of production, publication, distribution, manufacture, or copyright notice |
2007. |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
XVI, 216 p. |
| Other physical details |
online resource. |
| 336 ## - CONTENT TYPE |
|---|
| Content type term |
text |
| Content type code |
txt |
| Source |
rdacontent |
| 337 ## - MEDIA TYPE |
|---|
| Media type term |
computer |
| Media type code |
c |
| Source |
rdamedia |
| 338 ## - CARRIER TYPE |
|---|
| Carrier type term |
online resource |
| Carrier type code |
cr |
| Source |
rdacarrier |
| 347 ## - DIGITAL FILE CHARACTERISTICS |
|---|
| File type |
text file |
| Encoding format |
PDF |
| Source |
rda |
| 490 1# - SERIES STATEMENT |
|---|
| Series statement |
Ernst Schering Research Foundation Workshop, |
| International Standard Serial Number |
0947-6075 ; |
| Volume/sequential designation |
59 |
| 505 0# - FORMATTED CONTENTS NOTE |
|---|
| Formatted contents note |
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. |
| 520 ## - SUMMARY, ETC. |
|---|
| Summary, etc. |
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. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Medicine. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Pharmacology. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Biochemistry. |
| 650 14 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Biomedicine. |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Pharmacology/Toxicology. |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Medicine/Public Health, general. |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Biochemistry, general. |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Venitz, J. |
| Relator term |
editor. |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Sittner, W. |
| Relator term |
editor. |
| 710 2# - ADDED ENTRY--CORPORATE NAME |
|---|
| Corporate name or jurisdiction name as entry element |
SpringerLink (Online service) |
| 773 0# - HOST ITEM ENTRY |
|---|
| Title |
Springer eBooks |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY |
|---|
| Relationship information |
Printed edition: |
| International Standard Book Number |
9783540278672 |
| 830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE |
|---|
| Uniform title |
Ernst Schering Research Foundation Workshop, |
| International Standard Serial Number |
0947-6075 ; |
| Volume/sequential designation |
59 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS |
|---|
| Uniform Resource Identifier |
http://dx.doi.org/10.1007/978-3-540-49529-1 |
| 912 ## - |
|---|
| -- |
ZDB-2-SBL |
