New Drug Development
(Sprache: Englisch)
New Drug Development acquaints students and practitioners in the related fields of pharmaceutical sciences, clinical trials, and evidence-based medicine with the necessary study design concepts and statistical practices to allow them to understand how drug...
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New Drug Development acquaints students and practitioners in the related fields of pharmaceutical sciences, clinical trials, and evidence-based medicine with the necessary study design concepts and statistical practices to allow them to understand how drug developers plan and evaluate their drug development. Two goals of the book are to make the material accessible to readers with minimal background in research and to be straightforward enough for self-taught purposes. By bringing the topic from the early discovery phase to clinical trials and medical practice, the book provides an indispensable overview of an otherwise confusing and fragmented set of topics. The author's experience as a respected scientist, teacher of statistics, and one who has worked in the clinical trials arena makes him well suited to write such a treatise.
Klappentext zu „New Drug Development “
This book acquaints students and practitioners in the related fields of pharmaceutical sciences, clinical trials, and evidence-based medicine with the necessary study design concepts and statistical practices to allow them to understand how drug developers plan and evaluate their drug development. Two goals of the book are to make the material accessible to readers with minimal background in research and to be straightforward enough for self-taught purposes. By bringing the topic from the early discovery phase to clinical trials and medical practice, the book provides an indispensable overview of an otherwise confusing and fragmented set of topics. The author's experience as a respected scientist, teacher of statistics, and one who has worked in the clinical trials arena makes him well suited to write such a treatise.
Inhaltsverzeichnis zu „New Drug Development “
PART I: INTRODUCTIONCHAPTER 1: NEW DRUG DEVELOPMENTCHAPTER 2: THE REGULATORY ENVIRONMENT FOR NEW DRUG DEVELOPMENTPART II: DRUG DISCOVERY AND NONCLINICAL RESEARCHCHAPTER 3: DRUG DISCOVERYCHAPTER 4: NONCLINICAL RESEARCHPART III: DESIGN, METHODOLOGY, AND ANALYSISCHAPTER 5: DESIGN AND METHODOLOGY IN CLINICAL TRIALSCHAPTER 6: STATISTICAL ANALYSISCHAPTER 7: STATISTICAL SIGNIFICANCE--EMPLOYMENT OF HYPOTHESIS TESTINGCHAPTER 8: CLINICAL SIGNIFICANCE--EMPLOYMENT OF CONFIDENCE INTERVALSCHAPTER 9: SAMPLE-SIZE ESTIMATIONPART IV: LIFECYCLE CLINICAL DEVELOPMENTCHAPTER 10: SAFETY ASSESSMENT IN CLINICAL TRIALSCHAPTER 11: EFFICACY ASSESSMENT IN CLINICAL TRIALSCHAPTER 12: PHARMACEUTICAL AND BIOPHARMACEUTICAL DRUG MANUFACTURINGCHAPTER 13: POSTMARKETING SURVEILLANCE AND EVIDENCE-BASED MEDICINEPART V: INTEGRATIVE DISCUSSIONCHAPTER 14: UNIFYING THEMES AND CONCLUDING COMMENTS047008023X3ENAbout the Authors.Acknowledgments.Introduction to the Second Edition.PartI: Introduction to Exploitation: Linux on x86.Chapter 1: Before You Begin.Chapter 2: Stack Overflows.Chapter 3: Shellcode.Chapter 4: Introduction to Format String Bugs.Chapter 5: Introduction to Heap Overflows.Part II: Other Platforms--Windows, Solaris, OS/X, and Cisco.Chapter 6: The Wild World of Windows.Chapter 7: Windows Shellcode.Chapter 8: Windows Overflows.Chapter 9: Overcoming Filters.Chapter 10: Introduction to Solaris Exploitation.Chapter 11: Advanced Solaris Exploitation.Chapter 12: OS X Shellcode.Chapter 13: Cisco IOS Exploitation.Chapter 14: Protection Mechanisms.Part III: Vulnerability Discovery.Chapter 15: Establishing a Working Environment.Chapter 16: Fault Injection.Chapter 17: The Art of Fuzzing.Chapter 18: Source Code Auditing: Finding Vulnerabilities in C-Based Languages.Chapter 19: Instrumented Investigation: A Manual Approach.Chapter 20: Tracing for Vulnerabilities.Chapter 21: Binary Auditing: Hacking Closed SourceSoftware.Part IV: Advanced Materials.Chapter 22: Alternative Payload Strategies.Chapter 23: Writing
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Exploits that Work in the Wild.Chapter 24: Attacking Database Software.Chapter 25: Unix Kernel Overflows.Chapter 26: Exploiting Unix Kernel Vulnerabilities.Chapter 27: Hacking the Windows Kernel.Index.
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Autoren-Porträt von J. R. Turner
J. Rick Turner, PhD, is Chairman of the Department of Clinical Research at Campbell University School of Pharmacy in Morrisville, North Carolina. A Fellow of the Society of Behavioral Medicine, his areas of interest include cardiovascular behavioral medicine, drug development, and clinical submissions. Dr. Turner has authored several books as well as more than fifty articles in professional journals, and he received a Commit to Product Development Award from GlaxoSmithKline in 2005.
Bibliographische Angaben
- Autor: J. R. Turner
- 2007, 296 Seiten, Gebunden, Englisch
- Verlag: Wiley & Sons
- ISBN-10: 047007373X
- ISBN-13: 9780470073735
Sprache:
Englisch
Rezension zu „New Drug Development “
"The author has the uncanny ability to reveal the essence of a complex topic without bogging down in superficialities." (Journal of Clinical Research Practices, September 2007)
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