Optimization Of Pharmaceutical R D Programs And Portfolios
DOWNLOAD
Download Optimization Of Pharmaceutical R D Programs And Portfolios PDF/ePub or read online books in Mobi eBooks. Click Download or Read Online button to get Optimization Of Pharmaceutical R D Programs And Portfolios book now. This website allows unlimited access to, at the time of writing, more than 1.5 million titles, including hundreds of thousands of titles in various foreign languages. If the content not found or just blank you must refresh this page
Optimization Of Pharmaceutical R D Programs And Portfolios
DOWNLOAD
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.
Bayesian Methods In Pharmaceutical Research
DOWNLOAD
Author : Emmanuel Lesaffre
language : en
Publisher: CRC Press
Release Date : 2020-04-15
Bayesian Methods In Pharmaceutical Research written by Emmanuel Lesaffre and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-04-15 with Medical categories.
Since the early 2000s, there has been increasing interest within the pharmaceutical industry in the application of Bayesian methods at various stages of the research, development, manufacturing, and health economic evaluation of new health care interventions. In 2010, the first Applied Bayesian Biostatistics conference was held, with the primary objective to stimulate the practical implementation of Bayesian statistics, and to promote the added-value for accelerating the discovery and the delivery of new cures to patients. This book is a synthesis of the conferences and debates, providing an overview of Bayesian methods applied to nearly all stages of research and development, from early discovery to portfolio management. It highlights the value associated with sharing a vision with the regulatory authorities, academia, and pharmaceutical industry, with a view to setting up a common strategy for the appropriate use of Bayesian statistics for the benefit of patients. The book covers: Theory, methods, applications, and computing Bayesian biostatistics for clinical innovative designs Adding value with Real World Evidence Opportunities for rare, orphan diseases, and pediatric development Applied Bayesian biostatistics in manufacturing Decision making and Portfolio management Regulatory perspective and public health policies Statisticians and data scientists involved in the research, development, and approval of new cures will be inspired by the possible applications of Bayesian methods covered in the book. The methods, applications, and computational guidance will enable the reader to apply Bayesian methods in their own pharmaceutical research.
29th European Symposium On Computer Aided Chemical Engineering
DOWNLOAD
Author : Anton A. Kiss
language : en
Publisher: Elsevier
Release Date : 2019-06-28
29th European Symposium On Computer Aided Chemical Engineering written by Anton A. Kiss and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-06-28 with Technology & Engineering categories.
The 29th European Symposium on Computer Aided Process Engineering, contains the papers presented at the 29th European Symposium of Computer Aided Process Engineering (ESCAPE) event held in Eindhoven, The Netherlands, from June 16-19, 2019. It is a valuable resource for chemical engineers, chemical process engineers, researchers in industry and academia, students, and consultants for chemical industries. - Presents findings and discussions from the 29th European Symposium of Computer Aided Process Engineering (ESCAPE) event
Platform Trial Designs In Drug Development
DOWNLOAD
Author : Zoran Antonijevic
language : en
Publisher: CRC Press
Release Date : 2018-12-07
Platform Trial Designs In Drug Development written by Zoran Antonijevic and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-12-07 with Mathematics categories.
Platform trials test multiple therapies in one indication, one therapy for multiple indications, or both. These novel clinical trial designs can dramatically increase the cost-effectiveness of drug development, leading to life-altering medicines for people suffering from serious illnesses, possibly at lower cost. Currently, the cost of drug development is unsustainable. Furthermore, there are particular problems in rare diseases and small biomarker defined subsets in oncology, where the required sample sizes for traditional clinical trial designs may not be feasible. The editors recruited the key innovators in this domain. The 20 articles discuss trial designs from perspectives as diverse as quantum computing, patient’s rights to information, and international health. The book begins with an overview of platform trials from multiple perspectives. It then describes impacts of platform trials on the pharmaceutical industry’s key stakeholders: patients, regulators, and payers. Next it provides advanced statistical methods that address multiple aspects of platform trials, before concluding with a pharmaceutical executive’s perspective on platform trials. Except for the statistical methods section, only a basic qualitative knowledge of clinical trials is needed to appreciate the important concepts and novel ideas presented.
Portfolio Program And Project Management In The Pharmaceutical And Biotechnology Industries
DOWNLOAD
Author : Pete Harpum
language : en
Publisher: John Wiley & Sons
Release Date : 2011-09-20
Portfolio Program And Project Management In The Pharmaceutical And Biotechnology Industries written by Pete Harpum 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 2011-09-20 with Science categories.
This book describes the way that pharmaceutical projects and programs are currently managed, and offers views from many highly experienced practitioners from within the industry on future directions for drug program management. The book integrates portfolio, program, and project management processes as fundamental for effective and efficient drug product development. Contributing expert authors provide their view of how the projectization approach can be taken forward by the drug industry over the coming years.
Portfolio Decision Analysis
DOWNLOAD
Author : Ahti Salo
language : en
Publisher: Springer Science & Business Media
Release Date : 2011-08-12
Portfolio Decision Analysis written by Ahti Salo 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 2011-08-12 with Business & Economics categories.
Portfolio Decision Analysis: Improved Methods for Resource Allocation provides an extensive, up-to-date coverage of decision analytic methods which help firms and public organizations allocate resources to 'lumpy' investment opportunities while explicitly recognizing relevant financial and non-financial evaluation criteria and the presence of alternative investment opportunities. In particular, it discusses the evolution of these methods, presents new methodological advances and illustrates their use across several application domains. The book offers a many-faceted treatment of portfolio decision analysis (PDA). Among other things, it (i) synthesizes the state-of-play in PDA, (ii) describes novel methodologies, (iii) fosters the deployment of these methodologies, and (iv) contributes to the strengthening of research on PDA. Portfolio problems are widely regarded as the single most important application context of decision analysis, and, with its extensive and unique coverage of these problems, this book is a much-needed addition to the literature. The book also presents innovative treatments of new methodological approaches and their uses in applications. The intended audience consists of practitioners and researchers who wish to gain a good understanding of portfolio decision analysis and insights into how PDA methods can be leveraged in different application contexts. The book can also be employed in courses at the post-graduate level.
Operations Research Applications In Health Care Management
DOWNLOAD
Author : Cengiz Kahraman
language : en
Publisher: Springer
Release Date : 2017-12-08
Operations Research Applications In Health Care Management written by Cengiz Kahraman and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-12-08 with Medical categories.
This book offers a comprehensive reference guide to operations research theory and applications in health care systems. It provides readers with all the necessary tools for solving health care problems. The respective chapters, written by prominent researchers, explain a wealth of both basic and advanced concepts of operations research for the management of operating rooms, intensive care units, supply chain, emergency medical service, human resources, lean health care, and procurement. To foster a better understanding, the chapters include relevant examples or case studies. Taken together, they form an excellent reference guide for researchers, lecturers and postgraduate students pursuing research on health care management problems. The book presents a dynamic snapshot on the field that is expected to stimulate new directions and stimulate new ideas and developments.
Women In Industrial And Systems Engineering
DOWNLOAD
Author : Alice E. Smith
language : en
Publisher: Springer Nature
Release Date : 2019-09-13
Women In Industrial And Systems Engineering written by Alice E. Smith and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-09-13 with Technology & Engineering categories.
This book presents a diversity of innovative and impactful research in the field of industrial and systems engineering (ISE) led by women investigators. After a Foreword by Margaret L. Brandeau, an eminent woman scholar in the field, the book is divided into the following sections: Analytics, Education, Health, Logistics, and Production. Also included is a comprehensive biography on the historic luminary of industrial engineering, Lillian Moeller Gilbreth. Each chapter presents an opportunity to learn about the impact of the field of industrial and systems engineering and women’s important contributions to it. Topics range from big data analysis, to improving cancer treatment, to sustainability in product design, to teamwork in engineering education. A total of 24 topics touch on many of the challenges facing the world today and these solutions by women researchers are valuable for their technical innovation and excellence and their non-traditional perspective. Found within each author’s biography are their motivations for entering the field and how they view their contributions, providing inspiration and guidance to those entering industrial engineering.
Quantitative Decisions In Drug Development
DOWNLOAD
Author : Christy Chuang-Stein
language : en
Publisher: Springer Nature
Release Date : 2021-09-03
Quantitative Decisions In Drug Development written by Christy Chuang-Stein and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-09-03 with Mathematics categories.
This book focuses on important decision points and evidence needed for making decisions at these points during the development of a new drug. It takes a holistic approach towards drug development by incorporating explicitly knowledge learned from the earlier part of the development and available historical information into decisions at later stages. In addition, the book shares lessons learned from several select examples published in the literature since the publication of the first edition. The second edition reiterates the need for making evidence-based Go/No Go decisions in drug development discussed in the first edition. It substantially expands several topics that have seen great advances since the publication of the first edition. The most noticeable additions include three adaptive trials conducted in recent years that offer excellent learning opportunities, the use of historical data in the design and analysis of clinical trials, and extending decision criteria to the cases when the primary endpoint is binary. The examples used to illustrate the additional materials all come from real trials with some post-trial reflections offered by the authors. The book begins with an overview of product development and regulatory approval pathways. It then discusses how to incorporate prior knowledge into study design and decision making at different stages of drug development. Prior knowledge includes information pertaining to historical controls. To assist decision making, the book discusses appropriate metrics and the formulation of go/no-go decisions for progressing a drug candidate to the next development stage. Using the concept of the positive predictive value in the field of diagnostics, the book leads readers to the assessment of the probability that an investigational product is effective given positive study outcomes. Lastly, the book points out common mistakes made by drug developers under the current drug-development paradigm. The book offers useful insights to statisticians, clinicians, regulatory affairs managers and decision-makers in the pharmaceutical industry who have a basic understanding of the drug-development process and the clinical trials conducted to support drug-marketing authorization. The authors provide software codes for select analytical approaches discussed in the book. The book includes enough technical details to allow statisticians to replicate the quantitative illustrations so that they can generate information to facilitate decision-making themselves.
Principles Of Clinical Pharmacology
DOWNLOAD
Author : Shiew-Mei Huang
language : en
Publisher: Academic Press
Release Date : 2012-09-18
Principles Of Clinical Pharmacology written by Shiew-Mei Huang and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-09-18 with Medical categories.
Principles of Clinical Pharmacology is a successful survey covering the pharmacologic principles underlying the individualization of patient therapy and contemporary drug development. This essential reference continues to focus on the basics of clinical pharmacology for the development, evaluation, and clinical use of pharmaceutical products while also addressing the most recent advances in the field. Written by leading experts in academia, industry, clinical and regulatory settings, the third edition has been thoroughly updated to provide readers with an ideal reference covering the wide range of important topics impacting clinical pharmacology as the discipline plays an increasingly significant role in drug development and regulatory science. The Third Edition has been endorsed by the American Society for Clinical Pharmacology and Therapeutics - Includes new chapters on imaging and the pharmacogenetic basis of adverse drug reactions - Offers an expanded regulatory section that addresses US and international issues and guidelines - Provides extended coverage of earlier chapters on transporters, pharmacogenetics and biomarkers and also illustrates the impact of gender on drug response - Presents a broadened discussion of clinical trials from Phase 1 to incorporate Phases II and III