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Bioequivalence and Statistics in Clinical Pharmacology (Bog, Paperback / softback, Engelsk)Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition explores statistics used in day-to-day... Læs mere
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Fundamental Concepts for New Clinical Trialists (Bog, Paperback / softback, Engelsk)This text describes the core scientific concepts of designing, data monitoring, analyzing, and reporting clinical trials as well as the practical aspects... Læs mere
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Bayesian Adaptive Methods for Clinical Trials (Bog, Hardback, Engelsk)Explores the growing role of Bayesian thinking in the rapidly changing world of clinical trial analysis. This book summarizes the state of clinical trial design and analysis and introduces the main ideas and potential benefits of a Bayesian alternative.
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Writing and Managing SOPs for GCP (Bog, Hardback, Engelsk)This book discusses managing SOPs for GCP from conception to retirement. It recommends approaches that have a direct impact on improving SOP and regulatory compliance.... Læs mere
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Adaptive Design Theory and Implementation Using SAS and R (Bog, Paperback / softback, Engelsk)Levering: Skaffevare (forvent 14 - 30 hverdage) -
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Economic Evaluation of Cancer Drugs: Using Clinical Trial and Real-World Data (Bog, Paperback / softback, Engelsk)The first book on the design and analysis of not only clinical trials but also how observational non-interventional data... Læs mere
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Textbook of Clinical Trials in Oncology: A Statistical Perspective (Bog, Paperback / softback, Engelsk)This is a textbook on the design and analysis of cancer clinical trials. It opens with a discussion of the choice of endpoints before moving onto discuss various types of trials across all phases of study, including basket trials, non-inferiority trials and multi-arm trials.
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Platform Trial Designs in Drug Development: Umbrella Trials and Basket Trials (Bog, Paperback / softback, Engelsk)Drug development sponsors cannot run individual trials for all products in all indications. This results in missed opportunities. Clinical trial programs known as “basket” and “umbrella” have demonstrated that multi-product, multi-indication trials can be efficient and feasible.
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Analytical Similarity Assessment in Biosimilar Product Development (Bog, Paperback / softback, Engelsk)Focuses on analytical similarity assessment in biosimilar product development following the FDA’s recommended stepwise approach for... Læs mere
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Statistical Methods for Survival Trial Design: With Applications to Cancer Clinical Trials Using R (Bog, Paperback / softback, Engelsk)This book focuses on clinical trial design and monitoring with time-to-event endpoints. Detail of... Læs mere
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Repeated Measures Design with Generalized Linear Mixed Models for Randomized Controlled Trials (Bog, Paperback / softback, Engelsk)This book provides the application of generalized linear mixed-effects models and its related models in the... Læs mere
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Applied Surrogate Endpoint Evaluation Methods with SAS and R (Bog, Paperback / softback, Engelsk)When a true endpoint is difficult to use because of such factors as long follow-up times or prohibitive cost, it is sometimes possible to use... Læs mere
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