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  • 1
    Unknown
    Boca Raton : Chapman & Hall/CRC
    Call number: C060:87
    Keywords: Biometry / methods
    Pages: xlvii, 771 p. : ill.
    Edition: 2nd ed.
    ISBN: 9781584888871
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    C060:87 departmental collection or stack – please contact the library
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  • 2
    Unknown
    Boca Raton : Chapman & Hall/CRC
    Call number: C060:119
    Keywords: Pharmacokinetics ; Empirical Research ; Models, Theoretical
    Description / Table of Contents: Empirical pharmacokinetics -- Numerical methods for PK parameter estimation -- Physiological aspects on pharmacokinetics -- Modelling the distribution process -- PK/PD modelling
    Pages: xiii, 170 p. : ill.
    ISBN: 9781420060652
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  • 3
    Unknown
    Boca Raton, Florida : CRC Press
    Call number: G040:72
    Keywords: Clinical trials / Statistical methods ; R (Computer program language) ; Clinical Trials as Topic / methods ; Software ; Statistics as Topic
    Abstract: "With examples based on the authors' 30 years of real-world experience in many areas of clinical drug development, this book provides a thorough presentation of clinical trial methodology. It presents detailed step-by-step illustrations on the implementation of the open-source software R. Case studies demonstrate how to select the appropriate clinical trial data. The authors introduce the corresponding biostatistical analysis methods, followed by the step-by-step data analysis using R. They also offer the R program for download, along with other essential data, on their website"--Provided by publisher
    Pages: xxiii, 363 pages : illustrations
    ISBN: 9781439840207
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  • 4
    Unknown
    Boca Raton : Chapman and Hall/CRC Press
    Call number: W26.5:108 ; G040:63
    Keywords: Clinical Trials ; Drugs / Testing ; Clinical Trials as Topic / methods ; Drug Approval / methods ; Drug Evaluation / methods ; Meta-Analysis as Topic
    Abstract: "Now viewed as its own scientific discipline, clinical trial methodology encompasses the methods required for the protection of participants in a clinical trial and the methods necessary to provide a valid inference about the objective of the trial. Drawing from the authors courses on the subject as well as the first authors more than 30 years working in the pharmaceutical industry, Clinical trial methodology emphasizes the importance of statistical thinking in clinical research and presents the methodology as a key component of clinical research. From ethical issues and sample size considerations to adaptive design procedures and statistical analysis, the book first covers the methodology that spans every clinical trial regardless of the area of application. Crucial to the generic drug industry, bioequivalence clinical trials are then discussed. The authors describe a parallel bioequivalence clinical trial of six formulations incorporating group sequential procedures that permit sample size re-estimation. The final chapters incorporate real-world case studies of clinical trials from the authors own experiences. These examples include a landmark Phase III clinical trial involving the treatment of duodenal ulcers and Phase III clinical trials that contributed to the first drug approved for the treatment of Alzheimers disease. Aided by the U.S. FDA, the U.S. National Institutes of Health, the pharmaceutical industry, and academia, the area of clinical trial methodology has evolved over the last six decades into a scientific discipline. This guide explores the processes essential for developing and conducting a quality clinical trial protocol and providing quality data collection, biostatistical analyses, and a clinical study report, all while maintaining the highest standards of ethics and excellence"--Provided by publisher
    Pages: xxv, 394 p. : ill.
    ISBN: 9781584889175
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    W26.5:108 available
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  • 5
    Call number: C060:175
    Keywords: Clinical Trials as Topic
    Description / Table of Contents: Overview of time-to-event endpoint methodology / Karl E. Peace -- Design (and monitoring) of clinical trials with time-to-event endpoints / Michael W. Sill and Larry Rubinstein -- Overview of time-to-event parametric methods / Karl E. Peace and Kao-Tai Tsai -- Overview of semiparametric inferential methods for time-to-event endpoints / Jianwen Cai and Donglin Zeng -- Overview of inferential methods for categorical time-to-event data / Eric V. Slud -- Overview of Bayesian inferential methods including time-to-event endpoints / Laura H. Gunn -- An efficient alternative to the Cox model for small time-to-event trials / Devan V. Mehrotra and Arthur J. Roth -- Estimation and testing for change in hazard for time-to-event endpoints / Rafia Bhore and Mohammad Huque -- Overview of descriptive and graphical methods for time-to-event data / Michael O'Connell and Bob Treder -- Design and analysis of analgesic trials / Akiko Okamoto, Julia Wang, and Surya Mohanty -- Design and analysis of analgesic trials with paired time-to-event endpoints / Zhu Wang and Hon Keung Tony Ng -- Time-to-event endpoint methods in antibiotic trials / Karl E. Peace --
    Notes: A Chapman & Hall Book.
    Pages: xvii, 598 p. : ill.
    ISBN: 9781420066395
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  • 6
    Call number: C060:227
    Keywords: Sample Size ; Biometry / methods
    Description / Table of Contents: Considerations prior to sample size calculation -- Comparing means -- Large sample tests for proportions -- Exact tests for proportions -- Tests for goodness-of-fit and contingency tables -- Comparing time-to-event data -- Group sequential methods -- Comparing variabilities -- Bioequivalence testing -- Dose response studies -- Microarray studies -- Bayesian sample size calculation -- Nonparametrics -- Sample size calculation in other areas
    Notes: "A CRC title."
    Pages: xiv, 465 p. : ill.
    Edition: 2nd ed.
    ISBN: 9781584889823
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  • 7
    Call number: ERW ; C060:214
    Keywords: Clinical trials / Statistical methods ; Clinical trials / Data processing ; Clinical Trials
    Notes: A Chapman & Hall Book.
    Pages: xvii, 381 p. : ill.
    ISBN: 9781466558151
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  • 8
    Call number: W26.5:147 ; C100:074
    Keywords: Antineoplastic agents / Development ; Clinical trials / Economic aspects ; Medical economics ; Antineoplastic Agents / economics ; Clinical Trials as Topic ; Drug Development / economics ; Models, Economic ; Cost-Benefit Analysis ; Medical economics
    Pages: xxvi, 415 pages : illustrations (black and white)
    ISBN: 9781498761307
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    W26.5:147 on loan
    C100:074 departmental collection or stack – please contact the library
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  • 9
    Unknown
    Boca Raton : Chapman & Hall/CRC
    Call number: W26.5:109 ; C060:217 ; G040:64
    Keywords: Clinical Trials as Topic ; Bayes Theorem
    Description / Table of Contents: (Publisher-supplied data) Statistical approaches for clinical trials -- Basics of Bayesian inference -- Phase I studies -- Phase II studies -- Phase III studies -- Special topics
    Abstract: "As has been well-discussed, the explosion of interest in Bayesian methods over the last 10 to 20 years has been the result of the convergence of modern computing power and ełcient Markov chain Monte Carlo (MCMC) algo- rithms for sampling from and summarizing posterior distributions. Prac- titioners trained in traditional, frequentist statistical methods appear to have been drawn to Bayesian approaches for three reasons. One is that Bayesian approaches implemented with the majority of their informative content coming from the current data, and not any external prior informa- tion, typically have good frequentist properties (e.g., low mean squared er- ror in repeated use). Second, these methods as now readily implemented in WinBUGS and other MCMC-driven software packages now oʼer the simplest approach to hierarchical (random eʼects) modeling, as routinely needed in longitudinal, frailty, spatial, time series, and a wide variety of other settings featuring interdependent data. Third, practitioners are attracted by the greater ʻexibility and adaptivity of the Bayesian approach, which permits stopping for ełcacy, toxicity, and futility, as well as facilitates a straightforward solution to a great many other specialized problems such as dose-nding, adaptive randomization, equivalence testing, and others we shall describe. This book presents the Bayesian adaptive approach to the design and analysis of clinical trials"--Provided by publisher
    Pages: xvii, 305 p. : ill.
    ISBN: 9781439825488
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    W26.5:109 available
    C060:217 departmental collection or stack – please contact the library
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  • 10
    Call number: C060:233
    Keywords: Drugs / Dose-response relationship ; Clinical Trials ; Clinical Trials, Phase I as Topic ; Dose-Response Relationship, Drug ; Biostatistics / methods ; Maximum Tolerated Dose
    Description / Table of Contents: Dose finding in clinical trials -- The continual reassessment method -- One-parameter dose toxicity models -- Theoretical properties -- Empirical properties -- Specifications of a CRM design -- Initial guesses of toxicity probabilities -- Least informative normal prior -- Initial design -- The time-to-event CRM -- CRM with multiparameter models -- When the CRM fails -- Stochastic approximation
    Pages: xv, 189 p. : ill.
    ISBN: 9781420091519
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