Cell and gene therapies have become the third major drug modality in pharmaceutical medicine of the 21st century after low molecular weight and antibody drugs. The gene therapy (GTx) field is rapidly advancing, and yet there are still fundamental sc...Lasīt vairāk
Bringing together leading statisticians, scientists, and clinicians from the pharmaceutical industry, academia, and regulatory agencies, this volume explores the rapidly growing area of multiple comparison research with an emphasis on pharmaceutic...Lasīt vairāk
Bayesian adaptive designs provide a critical approach to improve the efficiency and success rate of drug development that has been embraced by the US Food and Drug Administration (FDA). This is particularly important for early phase trials as they f...Lasīt vairāk
The book is designed to be accessible to readers with an intermediate knowledge of statistics, and can be a useful resource to statisticians, medical researchers, and regulatory personnel in drug development, as well as graduate students in the heal...Lasīt vairāk
The cost for bringing new medicine from discovery to market has nearly doubled in the last decade and has now reached 2.6 billion. There is an urgent need to make drug development less time-consuming and less costly. Innovative tri...Lasīt vairāk
The book is designed to be accessible to readers with an intermediate knowledge of statistics, and can be a useful resource to statisticians, medical researchers, and regulatory personnel in drug development, as well as graduate students in the heal...Lasīt vairāk
Praise for the Second Edition: this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study....Lasīt vairāk
Statistical methods that are commonly used in the review and approval process of regulatory submissions are usually referred to as statistics in regulatory science or regulatory statistics. In a broader sense, statistics in regulatory science can...Lasīt vairāk
The cost for bringing new medicine from discovery to market has nearly doubled in the last decade and has now reached 2.6 billion. There is an urgent need to make drug development less time-consuming and less costly. Innovative trial designs/anal...Lasīt vairāk
Since the publication of the first edition in 2000, there has been an explosive growth of literature in biopharmaceutical research and development of new medicines. This encyclopedia (1) provides a comprehensive and unified presentation of designs...Lasīt vairāk
Like the well-regarded and bestselling second edition, Sample Size Calculations in Clinical Research, Third Edition, presents statistical procedures for performing sample size calculations during various phases of clinical research and development. T...Lasīt vairāk
(Izdošanas datums: 18-Feb-2014, Hardback, Izdevniecība: John Wiley & Sons Inc, ISBN-13: 9781118152126)
This volume demonstrates how to use chromatography to measure the physicochemical and biomimetic properties of drug absorption and distribution in vivo for drug candidates in the early stages of drug discovery. It explains the drug discovery process;...Lasīt vairāk
In recent years, the variations of pharmaceutical products in efficacy and safety among different geographic regions due to ethic factors is a matter of great concern for sponsors as well as for regulatory authorities. However, the key issues lie on...Lasīt vairāk
Editors Cosmatos (early development and clinical pharmacology, Wyeth Research) and Chow (biostatistics and bioinformatics, Duke U. School of Medicine) use contributions from experts all over the world to explore the emerging field of translational me...Lasīt vairāk
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Senn (statistics, U. of Glasgow, UK) discusses the statistical issues related to drug development, presenting them in a way that life scientists working in the field can understand. First covering historical, philosophical, technical, and professiona...Lasīt vairāk
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Focusing on an integral part of pharmaceutical development, Sample Size Calculations in Clinical Research, Second Edition presents statistical procedures for performing sample size calculations during various phases of clinical research and developme...Lasīt vairāk
Alex Dmitrienko, Christy Chuang-Stein, Ralph D'Agostino
Sērija : SAS Press
(Izdošanas datums: 07-Feb-2007, Paperback / softback, Izdevniecība: SAS Institute, ISBN-13: 9781590478868)
This volume covers statistical methods used in drug discovery, animal toxicology studies, and clinical trials, for use by biostatisticians, pharmaceutical researchers, regulatory scientists, academic researchers, and graduate students. The 14 chapter...Lasīt vairāk
