| 000 -LEADER |
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| fixed length control field |
04803nam a22004575i 4500 |
| 001 - CONTROL NUMBER |
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| control field |
978-0-387-33706-7 |
| 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 |
20161121231025.0 |
| 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 |
100301s2006 xxu| s |||| 0|eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
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| International Standard Book Number |
9780387337067 |
| -- |
978-0-387-33706-7 |
| 024 7# - OTHER STANDARD IDENTIFIER |
|---|
| Standard number or code |
10.1007/0-387-33706-7 |
| Source of number or code |
doi |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER |
|---|
| Classification number |
RM1-950 |
| 072 #7 - SUBJECT CATEGORY CODE |
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| Subject category code |
MMG |
| Source |
bicssc |
| 072 #7 - SUBJECT CATEGORY CODE |
|---|
| Subject category code |
MED071000 |
| Source |
bisacsh |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER |
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| Classification number |
615 |
| Edition number |
23 |
| 245 10 - TITLE STATEMENT |
|---|
| Title |
Dose Finding in Drug Development |
| Medium |
[electronic resource] / |
| Statement of responsibility, etc. |
edited by Naitee Ting. |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE |
|---|
| Place of production, publication, distribution, manufacture |
New York, NY : |
| Name of producer, publisher, distributor, manufacturer |
Springer New York, |
| Date of production, publication, distribution, manufacture, or copyright notice |
2006. |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
XIV, 248 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 |
Statistics for Biology and Health, |
| International Standard Serial Number |
1431-8776 |
| 505 0# - FORMATTED CONTENTS NOTE |
|---|
| Formatted contents note |
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 -- Multiple Comparison Procedures in Dose Response Studies -- Partitioning Tests in Dose–Response Studies with Binary Outcomes -- Analysis of Dose–Response Relationship Based on Categorical Outcomes -- Power and Sample Size for Dose Response Studies. |
| 520 ## - SUMMARY, ETC. |
|---|
| Summary, etc. |
When you go to the pharmacy and fill a prescription, have you ever wondered if the dose of the medication is right for you? Can the dose be too low so that the drug will not work? Can the dose be too high that it may cause some potential problem? How do people learn about dosing information? This book answers some of these questions. 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. Naitee Ting received his Ph. D. in statistics from Colorado State University in 1987 and joined Pfizer Research right after obtaining his Ph. D. Dr. Ting is currently an Associate Director of Biostatistics in Pfizer Global Research and Development, supporting clinical development of new drugs. He has over 18 years of experiences in designing and analyzing late phase clinical trials. During his tenure at Pfizer, Dr. Ting has published more than 20 statistical papers in peer-reviewed journals and book chapters. He has also taught clinical trials courses at the University of Connecticut and University of Rhode Island. |
| 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 |
Statistics. |
| 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 |
Statistics for Life Sciences, Medicine, Health Sciences. |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Ting, Naitee. |
| 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 |
9780387290744 |
| 830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE |
|---|
| Uniform title |
Statistics for Biology and Health, |
| International Standard Serial Number |
1431-8776 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS |
|---|
| Uniform Resource Identifier |
http://dx.doi.org/10.1007/0-387-33706-7 |
| 912 ## - |
|---|
| -- |
ZDB-2-SMA |
