| Description |
1 online resource (xiv, 248 pages) : illustrations |
| Series |
Statistics for biology and health |
|
Statistics for biology and health.
|
| Contents |
Front Matter; Introduction 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 |
| Summary |
"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."--Jacket |
| Bibliography |
Includes bibliographical references |
| In |
Springer e-books |
| Subject |
Drugs -- Dose-response relationship -- Mathematics
|
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Drug development.
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Drugs -- Dose-response relationship.
|
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Dose-Response Relationship, Drug
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Drug Compounding
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MEDICAL -- Drug Guides.
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MEDICAL -- Pharmacology.
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MEDICAL -- Pharmacy.
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MEDICAL -- Nursing -- Pharmacology.
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Drug development.
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Dose-response relationship, Drug.
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Drug Compounding.
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Drugs -- Dose-response relationship -- Mathematics.
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Drogas -- Matemáticas
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Drugs -- Dose-response relationship
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Drug development
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| Form |
Electronic book
|
| Author |
Ting, Naitee
|
| LC no. |
2005935288 |
| ISBN |
9780387290744 |
|
0387290745 |
|
9780387337067 |
|
0387337067 |
|
6610726647 |
|
9786610726646 |
|
