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A Western-Based Approach to Analyzing TCMs In recent years, many pharmaceutical companies and clinical research organizations have been focusing on th...Lees meer
Like the well-regarded and bestselling second edition, Sample Size Calculations in Clinical Research, Third Edition , presents statistical procedures ...Lees meer
Emphasizing the role of good statistical practices (GSP) in drug research and formulation, this book outlines important statistics applications for ea...Lees meer
"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing...Lees meer
Preeminent Experts Update a Well-Respected Book Taking into account the regulatory and scientific developments that have occurred since the second edi...Lees meer
Written by a top biostatistics researcher, this is the first book entirely devoted to the statistical design and analysis of biosimilarity and interch...Lees meer
"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing...Lees meer
Statistical methods that are commonly used in the review and approval process of regulatory submissions are usually referred to as statistics in regul...Lees meer
This book focuses on analytical similarity assessment in biosimilar product development following the FDA's recommended stepwise approach for obtainin...Lees meer
This is the first book entirely devoted to the design and analysis of TCM development from a Western perspective, i.e., evidence-based clinical resear...Lees meer
Praise for the Second Edition: "...a grand feast for biostatisticians. It stands ready to satisfy the appetite of any pharmaceutical scientist with a ...Lees meer
Statistical methods that are commonly used in the review and approval process of regulatory submissions are usually referred to as statistics in regul...Lees meer
The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability d...Lees meer
Written by a top biostatistics researcher, this is the first book entirely devoted to the statistical design and analysis of biosimilarity and interch...Lees meer
Written by one of the preeminent experts in the field, this book covers commonly encountered controversial statistical issues in clinical trials and, ...Lees meer
This work details the statistical inference of linear models including parameter estimation, hypothesis testing, confidence intervals, and prediction....Lees meer
This second edition reflects recent developments and regulatory positions on the use of adaptive designs in clinical trials. It unifies the vast and c...Lees meer
Emphasizing the role of good statistical practices (GSP) in drug research and formulation, this book outlines important statistics applications for ea...Lees meer
Illustrating how stability studies play an important role in drug safety and quality assurance, this book introduces the basic concepts of stability t...Lees meer
Preeminent Experts Update a Well-Respected Book Taking into account the regulatory and scientific developments that have occurred since the second edi...Lees meer
Innovative Methods for Rare Diseases Drug Development focuses on biostatistical applications in terms of design and analysis in pharmaceutical researc...Lees meer
In clinical trial practice, controversial statistical issues inevitably occur regardless of the compliance with good statistical practice and good cli...Lees meer
With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA's recent draft guidance, a new edition of...Lees meer
Sample size calculation plays an important role in clinical research. It is common to observe discrepancies among study objectives, study design, stat...Lees meer