Dose Finding And Beyond In Biopharmaceutical Development PDF Download
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Author | : Jingjing Ye |
Publisher | : Springer |
Total Pages | : 0 |
Release | : 2024-11-01 |
Genre | : Medical |
ISBN | : 9783031671098 |
Download Dose Finding and Beyond in Biopharmaceutical Development Book in PDF, ePub and Kindle
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.
Author | : Naitee Ting |
Publisher | : Springer Science & Business Media |
Total Pages | : 262 |
Release | : 2006-12-29 |
Genre | : Medical |
ISBN | : 0387337067 |
Download Dose Finding in Drug Development Book in PDF, ePub and Kindle
If you have ever wondered when visiting the pharmacy how the dosage of your prescription is determined this book will answer your questions. Dosing information on drug labels is based on discussion between the pharmaceutical manufacturer and the drug regulatory agency, and the label is a summary of results obtained from many scientific experiments. The book introduces the drug development process, the design and the analysis of clinical trials. Many of the discussions are based on applications of statistical methods in the design and analysis of dose response studies. Important procedural steps from a pharmaceutical industry perspective are also examined.
Author | : Ronald P. Evens |
Publisher | : Springer Science & Business Media |
Total Pages | : 394 |
Release | : 2007-08-14 |
Genre | : Medical |
ISBN | : 0387329781 |
Download Drug and Biological Development Book in PDF, ePub and Kindle
This book offers a complete discussion of product development in the pharmaceutical and biotechnology industries from discovery, to product launch, through life cycle management. The book is organized for optimal usefulness in the education and training of health care professionals (MD, PharmD, PhD), at universities. The format is a set of figures, tables and lists, along with detailed narrative descriptions, including real-life examples, illustrations, controversies in industry, and references. The editors and authors of the book are industry and research experts in a variety of disciplines.
Author | : J. Venitz |
Publisher | : Springer Science & Business Media |
Total Pages | : 224 |
Release | : 2007-03-06 |
Genre | : Medical |
ISBN | : 3540495290 |
Download Appropriate Dose Selection - How to Optimize Clinical Drug Development Book in PDF, ePub and Kindle
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.
Author | : Ed Naitee Ting |
Publisher | : |
Total Pages | : 262 |
Release | : 2008-12-01 |
Genre | : |
ISBN | : 9788184891515 |
Download Dose Finding In Drug Development Book in PDF, ePub and Kindle
Author | : Institute of Medicine |
Publisher | : National Academies Press |
Total Pages | : 107 |
Release | : 2014-02-06 |
Genre | : Medical |
ISBN | : 0309292492 |
Download Improving and Accelerating Therapeutic Development for Nervous System Disorders Book in PDF, ePub and Kindle
Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.
Author | : Susanna Wu-Pong |
Publisher | : Springer Science & Business Media |
Total Pages | : 374 |
Release | : 2010-01-11 |
Genre | : Medical |
ISBN | : 1597455326 |
Download Biopharmaceutical Drug Design and Development Book in PDF, ePub and Kindle
This book provides a comprehensive examination of the newest biopharmaceutical drugs. Among the drugs discussed are ones in the categories of monoclonal antibodies for in-vivo use, cytokines, growth factors, enzymes, immunomodulators, thrombolytics, and immonotherapies including vaccines. Additionally, the volume examines new and emerging technologies, and contains a review of the Human Genome Project.
Author | : Institute of Medicine |
Publisher | : National Academies Press |
Total Pages | : 442 |
Release | : 2011-04-03 |
Genre | : Medical |
ISBN | : 0309158060 |
Download Rare Diseases and Orphan Products Book in PDF, ePub and Kindle
Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Author | : Rajesh Krishna |
Publisher | : CRC Press |
Total Pages | : 328 |
Release | : 2006-05 |
Genre | : Medical |
ISBN | : |
Download Dose Optimization in Drug Development Book in PDF, ePub and Kindle
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.
Author | : Shivaani Kummar |
Publisher | : Academic Press |
Total Pages | : 234 |
Release | : 2018-05-22 |
Genre | : Medical |
ISBN | : 0128125705 |
Download Novel Designs of Early Phase Trials for Cancer Therapeutics Book in PDF, ePub and Kindle
Novel Designs of Early Phase Trials for Cancer Therapeutics provides a comprehensive review by leaders in the field of the process of drug development, the integration of molecular profiling, the changes in early phase trial designs, and endpoints to optimally develop a new generation of cancer therapeutics. The book discusses topics such as statistical perspectives on cohort expansions, the role and application of molecular profiling and how to integrate biomarkers in early phase trials. Additionally, it discusses how to incorporate patient reported outcomes in phase one trials. This book is a valuable resource for medical oncologists, basic and translational biomedical scientists, and trainees in oncology and pharmacology who are interested in learning how to improve their research by using early phase trials. Brings a comprehensive review and recommendations for new clinical trial designs for modern cancer therapeutics Provides the reader with a better understanding on how to design and implement early phase oncology trials Presents a better and updated understanding of the process of developing new treatments for cancer, the exciting scientific advances and how they are informing drug development