Appropriate Dose Selection How To Optimize Clinical Drug Development
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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.
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
Release Date : 2009-09-02
Appropriate Dose Selection How To Optimize Clinical Drug Development written by J. Venitz and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-09-02 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.
New Approaches To Drug Discovery
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Author : Ulrich Nielsch
language : en
Publisher: Springer
Release Date : 2016-03-30
New Approaches To Drug Discovery written by Ulrich Nielsch and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-03-30 with Medical categories.
This volume gives an overview of state of the art technologies and future developments in the field of preclinical pharmaceutical research. A balanced mix of experts from academia and industry give insight in selected new developments in the drug discovery pathway. The topics cover the different parts of the drug discovery process, starting with new developments in the target identification and validation area. The lead generation part as a next step focuses on the requirements and technologies to identify new small molecules as lead compounds for further optimization; in a second section the technologies to identify biologics as leads are addressed. The final part focuses on the pharmacological models and technologies to characterize new compounds and the impact of biomarkers to facilitate the transfer of drug candidates into the development phase.
Principles And Practice Of Geriatric Psychiatry
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Author : Mohammed T. Abou-Saleh
language : en
Publisher: John Wiley & Sons
Release Date : 2011-01-04
Principles And Practice Of Geriatric Psychiatry written by Mohammed T. Abou-Saleh 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 2011-01-04 with Medical categories.
The renowned Principles and Practice of Geriatric Psychiatry, now in its third edition, addresses the social and biological concepts of geriatric mental health from an international perspective. Featuring contributions by distinguished authors from around the world, the book offers a distinctive angle on issues in this continually developing discipline. Principles and Practice of Geriatric Psychiatry provides a comprehensive review of: geriatric psychiatry spanning both psychiatric and non-psychiatric disorders scientific advances in service development specific clinical dilemmas New chapters on: genetics of aging somatoform disorders epidemiology of substance abuse somatoform disorders care of the dying patient Continuing the practice of earlier editions, the major sections of the book address aging, diagnosis and assessment and clinical conditions, incorporating an engaging discussion on substance abuse and schizophrenic disorders. Shorter sections include the presentation of mental illness in elderly people from different cultures—one of the most popular sections in previous editions. Learning and behavioural studies, as well as models of geriatric psychiatry practice, are covered extensively. This book provides a detailed overview of the entire range of mental illness in old age, presented within an accessible format. Principles and Practice of Geriatric Psychiatry is an essential read for psychiatrists, geriatricians, neurologists and psychologists. It is of particular use for instructors of general psychiatry programs and their residents.
Essential Cns Drug Development
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Author : Amir Kalali
language : en
Publisher: Cambridge University Press
Release Date : 2012-06-07
Essential Cns Drug Development written by Amir Kalali and has been published by Cambridge University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-06-07 with Medical categories.
Central Nervous System disorders have an enormous impact on individuals and on society as a whole. The development of better treatments is crucial and is a major focus of pharmaceutical and biotechnology companies. This book explains the complicated process of CNS drug development in a way that is engaging for any interested professional or student. Chapters cover each stage of drug development, from pre-clinical research through all phases of clinical trials, to reporting to the regulatory authorities. Other key issues covered include strategic considerations, regulatory constraints, dissemination of results and ethical considerations. The user-friendly format and style enable readers to find important information quickly and easily. Written and edited by experts from different sectors actively engaged in CNS drug development, this is a unique resource for drug developers, investigators, academics and clinicians.
Optimization Of Pharmaceutical R D Programs And Portfolios
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Author : Zoran Antonijevic
language : en
Publisher: Springer
Release Date : 2014-10-10
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 2014-10-10 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.
Pharmaceutical Drug Product Development And Process Optimization
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Author : Sarwar Beg
language : en
Publisher: CRC Press
Release Date : 2020-05-01
Pharmaceutical Drug Product Development And Process Optimization written by Sarwar Beg and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-05-01 with Business & Economics categories.
Pharmaceutical manufacturers are constantly facing quality crises of drug products, leading to an escalating number of product recalls and rejects. Due to the involvement of multiple factors, the goal of achieving consistent product quality is always a great challenge for pharmaceutical scientists. This volume addresses this challenge by using the Quality by Design (QbD) concept, which was instituted to focus on the systematic development of drug products with predefined objectives to provide enhanced product and process understanding. This volume presents and discusses the vital precepts underlying the efficient, effective, and cost effective development of pharmaceutical drug products. It focuses on the adoption of systematic quality principles of pharmaceutical development, which is imperative in achieving continuous improvement in end-product quality and also leads to reducing cost, time, and effort, while meeting regulatory requirements. The volume covers the important new advances in the development of solid oral dosage forms, modified release oral dosage forms, parenteral dosage forms, semisolid dosage forms, transdermal drug, delivery systems, inhalational dosage forms, ocular drug delivery systems, nanopharmaceutical products, and nanoparticles for oral delivery.
Handbook Of Anticancer Pharmacokinetics And Pharmacodynamics
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Author : Michelle A. Rudek
language : en
Publisher: Springer Science & Business Media
Release Date : 2014-01-10
Handbook Of Anticancer Pharmacokinetics And Pharmacodynamics written by Michelle A. Rudek 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 2014-01-10 with Medical categories.
There are many steps on the road from discovery of an anticancer drug to securing its final approval by the Food and Drug Administration. In this thoroughly updated and expanded second edition of the Handbook of Anticancer Pharmacokinetics and Pharmacodynamics, leading investigators synthesize an invaluable overview of the experimental and clinical processes of anticancer drug development, creating a single indispensable reference that covers all the steps from the identification of cancer-specific molecular targets to screening techniques and the development and validation of bioanalytical methods to clinical trial design and all phases of clinical trials. The authors have included new material on phase 0 trials in oncology, organ dysfunction trials, drug formulations and their impact on anticancer drug PK/PD including strategies to improve drug delivery, pharmacogenomics and cancer therapy, high throughput platforms in drug metabolism and transport pharmacogenetics, imaging in drug development and nanotechnology in cancer. Authoritative and up-to-date, Handbook of Anticancer Pharmacokinetics and Pharmacodynamics, 2nd Edition provides in one comprehensive and highly practical volume a detailed step-by-step guide to the successful design and approval of anticancer drugs. Road map to anticancer drug development from discovery to NDA submission Discussion of molecular targets and preclinical screening Development and validation of bioanalytical methods Chapters on clinical trial design and phase 0, I, II, III clinical trials Pharmacokinetics, pharmacodynamics, pharmacogenomics, and pharmacogenetics of anticancer agents Review of the drug development process from both laboratory and clinical perspectives New technological advances in imaging, high throughput platforms, and nanotechnology in anticancer drug development
Pharmaceutical Medicine And Translational Clinical Research
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Author : Divya Vohora
language : en
Publisher: Academic Press
Release Date : 2017-11-13
Pharmaceutical Medicine And Translational Clinical Research written by Divya Vohora and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-11-13 with Medical categories.
Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features. As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource.