Dose Finding In Drug Development
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Dose Finding In Drug Development
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Author : Naitee Ting
language : en
Publisher: Springer Science & Business Media
Release Date : 2006-12-29
Dose Finding In Drug Development written by Naitee Ting and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-12-29 with Medical categories.
This book emphasizes dose selection issues from a statistical point of view. It presentsstatisticalapplicationsinthedesignandanalysisofdose–responsestudies. The importance of this subject can be found from the International Conference on Harmonization (ICH) E4 Guidance document. Establishing the dose–response relationship is one of the most important act- ities in developing a new drug. A clinical development program for a new drug can be broadly divided into four phases – namely Phases I, II, III, and IV. Phase I clinical trials are designed to study the clinical pharmacology. Information - tained from these studies will help in designing Phase II studies. Dose–response relationshipsareusuallystudiedinPhaseII.PhaseIIIclinicaltrialsarelarge-scale, long-term studies. These studies serve to con?rm ?ndings from Phases I and II. ResultsobtainedfromPhasesI,II,andIIIclinicaltrialswouldthenbedocumented and submitted to regulatory agencies for drug approval. In the United States, - viewers from Food and Drug Administration (FDA) review these documents and make a decision to approve or to reject this New Drug Application (NDA). If the new drug is approved, then Phase IV studies can be started. Phase IV clinical trials are also known as postmarketing studies.
Dose Optimization In Drug Development
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Author : Rajesh Krishna
language : en
Publisher: CRC Press
Release Date : 2006-05
Dose Optimization In Drug Development written by Rajesh Krishna and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-05 with Medical categories.
This reference provides a concise overview of the key principles in dose selection and optimization and demonstrates applicability to recent successful new drug applications. Compiling key issues and current research on safety, efficacy, and clinical pharmacology, and PK-PD, this volume critically highlights the multidisciplinary nature of drug development and spans the fields of pharmacokinetics, clinical pharmacology, biostatistics, and experimental medicine.
Dose Finding By The Continual Reassessment Method
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Author : Ying Kuen Cheung
language : en
Publisher: CRC Press
Release Date : 2011-03-29
Dose Finding By The Continual Reassessment Method written by Ying Kuen Cheung and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-03-29 with Mathematics categories.
As clinicians begin to realize the important role of dose-finding in the drug development process, there is an increasing openness to "novel" methods proposed in the past two decades. In particular, the Continual Reassessment Method (CRM) and its variations have drawn much attention in the medical community, though it has yet to become a commonplace tool. To overcome the status quo in phase I clinical trials, statisticians must be able to design trials using the CRM in a timely and reproducible manner. A self-contained theoretical framework of the CRM for researchers and graduate students who set out to learn and do research in the CRM and dose-finding methods in general, Dose Finding by the Continual Reassessment Method features: Real clinical trial examples that illustrate the methods and techniques throughout the book Detailed calibration techniques that enable biostatisticians to design a CRM in timely manner Limitations of the CRM are outlined to aid in correct use of method This book supplies practical, efficient dose-finding methods based on cutting edge statistical research. More than just a cookbook, it provides full, unified coverage of the CRM in addition to step-by-step guidelines to automation and parameterization of the methods used on a regular basis. A detailed exposition of the calibration of the CRM for applied statisticians working with dose-finding in phase I trials, the book focuses on the R package ‘dfcrm’ for the CRM and its major variants. The author recognizes clinicians’ skepticism of model-based designs, and addresses their concerns that the time, professional, and computational resources necessary for accurate model-based designs can be major bottlenecks to the widespread use of appropriate dose-finding methods in phase I practice. The theoretically- and empirically-based methods in Dose Finding by the Continual Reassessment Method will lessen the statistician’s burden and encourage the continuing development and implementation of model-based dose-finding methods.
Dose Finding And Beyond In Biopharmaceutical Development
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Author : Jingjing Ye
language : en
Publisher: Springer Nature
Release Date : 2024-10-28
Dose Finding And Beyond In Biopharmaceutical Development written by Jingjing Ye and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-10-28 with Medical categories.
This book covers topics in 2 parts: 1) Review of FDA Guidance, 2) Novel Designs and Analyses. While covering basic principles of dose finding, this book details advancements made in drug development. Finding the right dose(s) is one of the most important objectives in new drug development. In Phase I clinical development, one of the objectives is to escalate test doses from low to high. The low doses should be safe, then escalate up to the maximally tolerable dose (MTD). Phase II clinical trials then lower test doses to the minimal efficacious dose (MinED). Dose range of a study drug can be thought of as the doses between MinED and MTD. From this dose range, one or a few doses are selected for Phase III confirmation. In practice, dose finding is a very difficult in every phase of clinical development for new drugs. The editors brought distinguished researchers and practitioners in biopharmaceuticals and universities, to discuss the statistical procedures, useful methods, and their novel applications in dose finding. The chapters in the book present emerging topics in dose-finding and related interdisciplinary areas. This timely book is a valuable resource to stimulate the development of this growing and exciting field in drug development.
Statistical Issues In Drug Development
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Author : Stephen S. Senn
language : en
Publisher: John Wiley & Sons
Release Date : 2008-02-28
Statistical Issues In Drug Development written by Stephen S. Senn and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-02-28 with Medical categories.
Drug development is the process of finding and producingtherapeutically useful pharmaceuticals, turning them into safe andeffective medicine, and producing reliable information regardingthe appropriate dosage and dosing intervals. With regulatoryauthorities demanding increasingly higher standards in suchdevelopments, statistics has become an intrinsic and criticalelement in the design and conduct of drug development programmes. Statistical Issues in Drug Development presents anessential and thought provoking guide to the statistical issues andcontroversies involved in drug development. This highly readable second edition has been updated toinclude: Comprehensive coverage of the design and interpretation ofclinical trials. Expanded sections on missing data, equivalence, meta-analysisand dose finding. An examination of both Bayesian and frequentist methods. A new chapter on pharmacogenomics and expanded coverage ofpharmaco-epidemiology and pharmaco-economics. Coverage of the ICH guidelines, in particular ICH E9,Statistical Principles for Clinical Trials. It is hoped that the book will stimulate dialogue betweenstatisticians and life scientists working within the pharmaceuticalindustry. The accessible and wide-ranging coverage make itessential reading for both statisticians and non-statisticiansworking in the pharmaceutical industry, regulatory bodies andmedical research institutes. There is also much to benefitundergraduate and postgraduate students whose courses include amedical statistics component.
Dose Finding In Drug Development
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Author : Ed Naitee Ting
language : en
Publisher:
Release Date : 2008-12-01
Dose Finding In Drug Development written by Ed Naitee Ting and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-12-01 with categories.
Phase Ii Clinical Development Of New Drugs
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Author : Naitee Ting
language : en
Publisher: Springer
Release Date : 2017-04-08
Phase Ii Clinical Development Of New Drugs written by Naitee Ting and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-04-08 with Medical categories.
This book focuses on how to appropriately plan and develop a Phase II program, and how to design Phase II clinical trials and analyze their data. It provides a comprehensive overview of the entire drug development process and highlights key questions that need to be addressed for the successful execution of Phase II, so as to increase its success in Phase III and for drug approval. Lastly it warns project team members of the common potential pitfalls and offers tips on how to avoid them.
Phase I Cancer Clinical Trials
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Author : Elizabeth A. Eisenhauer
language : en
Publisher: Oxford University Press
Release Date : 2015-03-20
Phase I Cancer Clinical Trials written by Elizabeth A. Eisenhauer and has been published by Oxford University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-03-20 with Medical categories.
Phase I trials are a critical first step in the study of novel cancer therapeutic approaches. Their primary goals are to identify the recommended dose, schedule and pharmacologic behavior of new agents or new combinations of agents and to describe the adverse effects of treatment. In cancer therapeutics, such studies have particular challenges. Due to the nature of the effects of treatment, most such studies are conducted in patients with advanced malignancy, rather than in healthy volunteers. Further, the endpoints of these trials are usually measures adverse effects rather than molecular target or anti-tumor effects. These factors render the design, conduct, analysis and ethical aspects of phase I cancer trials unique. As the only comprehensive book on this topic, Phase I Cancer Clinical Trials is a useful resource for oncology trainees or specialists interested in understanding cancer drug development. New to this edition are chapters on Phase 0 Trials and Immunotherapeutics, and updated information on the process, pitfalls, and logistics of Phase I Trials
Appropriate Dose Selection How To Optimize Clinical Drug Development
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Author : J. Venitz
language : en
Publisher: Springer Science & Business Media
Release Date : 2007-03-06
Appropriate Dose Selection How To Optimize Clinical Drug Development written by J. Venitz and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-03-06 with Medical categories.
Optimal dose individualization has become more important in improving clinical efficacy and safety. This is due in part to the variability in drug response. Therefore, the role of optimal dose finding in early clinical drug development so as to maximize successful clinical use is emphasized. This book reviews innovative methods, tools and examples of rational drug development strategies, particularly for novel oncological agents.
Small Clinical Trials
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2001-02-01
Small Clinical Trials written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001-02-01 with Medical categories.
Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.