Dose Optimization In Drug Development

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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.
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.
The Drug Development Paradigm In Oncology
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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2018-02-12
The Drug Development Paradigm In Oncology written by National Academies of Sciences, Engineering, and 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 2018-02-12 with Medical categories.
Advances in cancer research have led to an improved understanding of the molecular mechanisms underpinning the development of cancer and how the immune system responds to cancer. This influx of research has led to an increasing number and variety of therapies in the drug development pipeline, including targeted therapies and associated biomarker tests that can select which patients are most likely to respond, and immunotherapies that harness the body's immune system to destroy cancer cells. Compared with standard chemotherapies, these new cancer therapies may demonstrate evidence of benefit and clearer distinctions between efficacy and toxicity at an earlier stage of development. However, there is a concern that the traditional processes for cancer drug development, evaluation, and regulatory approval could impede or delay the use of these promising cancer treatments in clinical practice. This has led to a number of effortsâ€"by patient advocates, the pharmaceutical industry, and the Food and Drug Administration (FDA)â€"to accelerate the review of promising new cancer therapies, especially for cancers that currently lack effective treatments. However, generating the necessary data to confirm safety and efficacy during expedited drug development programs can present a unique set of challenges and opportunities. To explore this new landscape in cancer drug development, the National Academies of Sciences, Engineering, and Medicine developed a workshop held in December 2016. This workshop convened cancer researchers, patient advocates, and representatives from industry, academia, and government to discuss challenges with traditional approaches to drug development, opportunities to improve the efficiency of drug development, and strategies to enhance the information available about a cancer therapy throughout its life cycle in order to improve its use in clinical practice. This publication summarizes the presentations and discussions from the workshop.
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.
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
Early Drug Development
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Author : Mitchell N. Cayen
language : en
Publisher: John Wiley & Sons
Release Date : 2011-02-25
Early Drug Development written by Mitchell N. Cayen 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 2011-02-25 with Medical categories.
The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) application. By explaining the nuts and bolts of preclinical development activities and their interplay in effectively identifying successful clinical candidates, the book helps pharmaceutical scientists determine what types of discovery and preclinical research studies are needed in order to support a submission to regulatory agencies.
Applications Of Pharmacokinetic Principles In Drug Development
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Author : Rajesh Krishna
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-12-06
Applications Of Pharmacokinetic Principles In Drug Development written by Rajesh Krishna 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 2012-12-06 with Medical categories.
This volume is an important advancement in the application ofpharmacokinetic (PK) and pharmacodynamic (PO) principles to . drug development. The series of topics presented deal with the application of these tools to everyday decisions that a pharmaceutical scientist encounters. The ability to integrate these topics using PK and PO methods has optimized drug development pathways in the clinic. New technologies in the areas of in vitro assays that are more predictive of human absorption and metabolism and advancement in bioanalytical assays are leading the way to minimize drug failures in later, more expensive clinical development programs. of Pharmacokinetics and pharmacodynamics have become an important component understanding the drug action on the body and is becoming increasingly important in drug labeling due to it's potential for predicting drug behavior in populations that may be difficult to study in adequate numbers during drug development. The ability to correlate drug exposure to effect and model it during the drug development value chain provides valuable insight into optimizing the next steps to derive maximum information from each study. These principles and modeling techniques have resulted in an expanded and integrated view of PK and PO and have led to the expectations that we may be able to optimally design clinical trials and eventually lead us to identifying the optimal therapy for the patient, while minimizing cost and speeding up drug development. There is wide utility for the book both as a text and as a reference.
Optimization Of Pharmaceutical R D Programs And Portfolios
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Author : Zoran Antonijevic
language : en
Publisher: Springer
Release Date : 2016-08-23
Optimization Of Pharmaceutical R D Programs And Portfolios written by Zoran Antonijevic and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-08-23 with Business & Economics categories.
Very little has been published on optimization of pharmaceutical portfolios. Moreover, most of published literature is coming from the commercial side, where probability of technical success (PoS) is treated as fixed, and not as a consequence of development strategy or design. In this book there is a strong focus on impact of study design on PoS and ultimately on the value of portfolio. Design options that are discussed in different chapters are dose-selection strategies, adaptive design and enrichment. Some development strategies that are discussed are indication sequencing, optimal number of programs and optimal decision criteria. This book includes chapters written by authors with very broad backgrounds including financial, clinical, statistical, decision sciences, commercial and regulatory. Many authors have long held executive positions and have been involved with decision making at a product or at a portfolio level. As such, it is expected that this book will attract a very broad audience, including decision makers in pharmaceutical R&D, commercial and financial departments. The intended audience also includes portfolio planners and managers, statisticians, decision scientists and clinicians. Early chapters describe approaches to portfolio optimization from big Pharma and Venture Capital standpoints. They have stronger focus on finances and processes. Later chapters present selected statistical and decision analysis methods for optimizing drug development programs and portfolios. Some methodological chapters are technical; however, with a few exceptions they require a relatively basic knowledge of statistics by a reader.
Optimizing The Drug Like Properties Of Leads In Drug Discovery
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Author : Ronald Borchardt
language : en
Publisher: Springer Science & Business Media
Release Date : 2007-12-31
Optimizing The Drug Like Properties Of Leads In Drug Discovery written by Ronald Borchardt 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 2007-12-31 with Medical categories.
This book arises from a workshop organized by the American Association of Pharmaceutical Scientists entitled "Optimizing the Drug-Like Properties of Leads in Drug Discovery," which took place in Parsippany, NJ in September 2004. The workshop focused on the optimization of the drug-like properties of leads in drug discovery. The volume outlines strategies and methodologies designed to guide pharmaceutical and biotechnology companies through the drug discovery and development process.