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Adaptive Design Methods in Clinical Trials
With new statistical and scientific issues arising in adaptive clinical trial design, including the ... more |
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Innovative Statistics in Regulatory Science
author Shein-Chung Chow, Ph.D. is currently a Professor at Duke University School of Medicine, Durham, NC. He was previously...... more |
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Innovative Methods for Rare Disease Drug Development
In the United States, a rare disease is defined by the Orphan Drug Act as a disorder or condition th... more |
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Sample Size Calculations in Clinical Research
Praise for the Second Edition: "... this is a useful, comprehensive compendium of almost every possi... more |
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Controversial Statistical Issues in Clinical Trials
In clinical trial practice, controversial statistical issues inevitably occur regardless of the comp... more |
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Statistical Design and Analysis of Stability Studies
The US Food and Drug Administration’s Report to the Nation in 2004 and 2005 indicated that one of th... more |
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Innovative Statistics in Regulatory Science
author Shein-Chung Chow, Ph.D. is currently a Professor at Duke University School of Medicine, Durham, NC. He was previously...... more |
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Biosimilars: Design and Analysis of Follow-on Biologics
As many biological products face losing their patents in the next decade, the pharmaceutical industr... more |
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Statistics in Drug Research: Methodologies and Recent Developments
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Quantitative Methods for Traditional Chinese Medicine Development
A Western-Based Approach to Analyzing TCMs In recent years, many pharmaceutical companies and clinic... more |
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Statistical Design and Analysis in Pharmaceutical Science
"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all... more |
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Analytical Similarity Assessment in Biosimilar Product Development
This book focuses on analytical similarity assessment in biosimilar product development following th... more |
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Sample Size Calculations in Clinical Research
Praise for the Second Edition: "... this is a useful, comprehensive compendium of almost every possi... more |
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Quantitative Methods for Hiv/AIDS Research
Quantitative Methods in HIV/AIDS Research provides a comprehensive discussion of modern statistical ... more |
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Biosimilar Drug Product Development
When a biological drug patent expires, alternative biosimilar products are developed. The developmen... more |
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Clinical Trials 3e
Praise for the Second Edition: ...a grand feast for biostatisticians. It stands ready to satisfy th... more |
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Biosimilars: Design and Analysis of Follow-On Biologics
As many biological products face losing their patents in the next decade, the pharmaceutical industr... more |
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Design and Analysis of Bridging Studies
As the development of medicines has become more globalized, the geographic variations in the efficac... more |
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Adaptive Design Methods in Clinical Trials
With new statistical and scientific issues arising in adaptive clinical trial design, including the ... more |
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Statistical Design and Analysis of Stability Studies
The US Food and Drug Administration s Report to the Nation in 2004 and 2005 indicated that one of th... more |
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Statistics in Drug Research: Methodologies and Recent Developments
Emphasizing the role of good statistical practices (GSP) in drug research and formulation, this book... more |
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Methodologies in Biosimilar Product Development
Methodologies for Biosimilar Product Development covers the practical and challenging issues that ar... more |
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Advanced Statistics in Regulatory Critical Clinical Initiatives
Advanced Statistics in Regulatory Critical Clinical Initiatives is focused on the critical clinical ... more |
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Methodologies in Biosimilar Product Development
Methodologies for Biosimilar Product Development covers the practical and challenging issues that ar... more |
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Handbook of Adaptive Designs in Pharmaceutical and Clinical Development
In response to the US FDA’s Critical Path Initiative, innovative adaptive designs are being used mor... more |
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Design and Analysis of Bioavailability and Bioequivalence Studies
Preeminent Experts Update a Well-Respected Book Taking into account the regulatory and scientific de... more |
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Analytical Similarity Assessment in Biosimilar Product Development
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Encyclopedia of Biopharmaceutical Statistics - Four Volume Set
organized by stages of biopharmaceutical development provides easy access to relevant topics. About the Editor: Shein-Chung Chow...... more |
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Quantitative Methods for Traditional Chinese Medicine Development
A Western-Based Approach to Analyzing TCMs In recent years, many pharmaceutical companies and clinic... more |
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Controversial Statistical Issues in Clinical Trials
In clinical trial practice, controversial statistical issues inevitably occur regardless of the comp... more |
|||
Handbook of Adaptive Designs in Pharmaceutical and Clinical Development
In response to the US FDA s Critical Path Initiative, innovative adaptive designs are being used mor... more |
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Encyclopedia of Biopharmaceutical Statistics
In recent years, there has been an explosive growth of biopharmaceutical and clinical research, incl... more |
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Design and Analysis of Bioavailability and Bioequivalence Studies
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Sample Size Calculations in Clinical Research: Includes Special Version of N-Solution 2007 Software
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Translational Medicine: Strategies and Statistical Methods
Examines Critical Decisions for Transitioning Lab Science to a Clinical Setting The development of t... more |
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Design and Analysis of Bioavailability and Bioequivalence Studies
Preeminent Experts Update a Well-Respected Book Taking into account the regulatory and scientific de... more |
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Sample Size Calculations in Clinical Research
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Adaptive Design Methods in Clinical Trials
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Design and Analysis of Clinical Trials: Concepts and Methodologies
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Encyclopedia of Biopharmaceutical Statistics
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Design and Analysis of Bioavailability and Bioequivalence Studies
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Design and Analysis of Animal Studies in Pharmaceutical Development
"Provides well-integrated, comprehensive coverage of all the major statistical designs and methods u... more |
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Statistical Design and Analysis in Pharmaceutical Science: Validation, Process Controls, and Stability
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Advanced Linear Models: Theory and Applications
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Design and Analysis of Bioavailability and Bioequivalence Studies
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Statistics in the Pharmaceutical Industry
The growth of the pharmaceutical industry over the past decade is astounding, but the impact of this... more |
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Design and Analysis of Animal Studies in Pharmaceutical Development
"Provides well-integrated, comprehensive coverage of all the major statistical designs and methods u... more |
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Design and Analysis of Bridging Studies
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Quantitative Methods for Hiv/AIDS Research
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Biosimilar Drug Product Development
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