The Early Phases
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The Application Of Function Point Analysis Fpa In The Early Phases Of The Application Life Cycle A Practical Manual Theory And Case Study
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Author : Paul Peeters, Jaap van Asperen, Martin Jacobs, Hans Vonk, and others
language : en
Publisher: Nesma
Release Date :
The Application Of Function Point Analysis Fpa In The Early Phases Of The Application Life Cycle A Practical Manual Theory And Case Study written by Paul Peeters, Jaap van Asperen, Martin Jacobs, Hans Vonk, and others and has been published by Nesma this book supported file pdf, txt, epub, kindle and other format this book has been release on with categories.
An Introduction To Statistics In Early Phase Trials
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Author : Steven Julious
language : en
Publisher: John Wiley & Sons
Release Date : 2010-01-19
An Introduction To Statistics In Early Phase Trials written by Steven Julious 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 2010-01-19 with Medical categories.
All new medicines and devices undergo early phase trials to assess, interpret and better understand their efficacy, tolerability and safety. An Introduction to Statistics in Early Phase Trials describes the practical design and analysis of these important early phase clinical trials and provides the crucial statistical basis for their interpretation. It clearly and concisely provides an overview of the most common types of trials undertaken in early phase clinical research and explains the different methodologies used. The impact of statistical technologies on clinical development and the statistical and methodological basis for making clinical and investment decisions are also explained. Conveys key ideas in a concise manner understandable by non-statisticians Explains how to optimise designs in a constrained or fixed resource setting Discusses decision making criteria at the end of Phase II trials Highlights practical day-to-day issues and reporting of early phase trials An Introduction to Statistics in Early Phase Trials is an essential guide for all researchers working in early phase clinical trial development, from clinical pharmacologists and pharmacokineticists through to clinical investigators and medical statisticians. It is also a valuable reference for teachers and students of pharmaceutical medicine learning about the design and analysis of clinical trials.
The Supporting Role Of Logistics During The Early Stage Of Retail Internationalisation
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Author : Linnea Haag
language : en
Publisher: Linköping University Electronic Press
Release Date : 2019-03-08
The Supporting Role Of Logistics During The Early Stage Of Retail Internationalisation written by Linnea Haag and has been published by Linköping University Electronic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-03-08 with categories.
Retail internationalisation refers to the establishment of retailers into foreign sales markets and is an important success factor for many retail chains. Logistics has been acknowledged as an important prerequisite and key component of retail internationalisation, enabling physical distribution to new foreign markets as well as ensuring customer satisfaction in terms of on-time delivery and product availability. Despite the recognition of logistics, logistics managers struggle to adapt their logistics organisation and operations in order to efficiently and effectively support retail internationalisation due to the complexity of operating in multiple markets. Previous research seldom mentions how logistics supports retail internationalisation, especially when retail chains are at the beginning of their retail-internationalisation journey. By exploring the supporting role of logistics during the early stage of retail internationalisation, retailers can better understand how logistics organisation and operations can be organised in order to successfully expand into foreign sales markets. Therefore, the purpose of this licentiate thesis is to: Explore the supporting role of logistics during the early stage of retail internationalisation. This licentiate thesis is based on an abductive, multiple-case-study approach that combines empirical data with literature in an iterative process in order to explore the supporting role of logistics during the early stage of retail internationalisation. The selected case companies were three large-sized Swedish retail chains that have recently established themselves into nearby foreign sales markets. The findings of this licentiate thesis suggest that logistics plays both a reactive and a proactive supporting role during the early stage of retail internationalisation. The reactive supporting role refers to logistics that adapts to predetermined conditions set by the retail company’s top management team. As a reactive supporter, the logistics organisation is typically involved at an operational level and scales up its logistics operations in order to supply multiple markets. Beyond its reactive role, logistics can also play a proactive supporting role. This refers to its involvement at a strategic level within the retail company where it can influence the conditions of retail internationalisation. When logistics is involved more proactively, its operations can become better aligned with the other company operations involved in retail internationalisation. Furthermore, proactive logistics support enables more efficient and effective logistics that can better cope with increased complexity as well as more effectively keeping track of logistics costs. In addition to these findings, the importance of top management has been identified as a key aspect of proactive logistics support. More specifically, logistics competence within the top management team enables logistics to be prioritised at a strategic level and to be better integrated during retail internationalisation, including during individual establishments into new markets. The findings also suggest that the importance of logistics increases over time during retail internationalisation. The more markets the retailer enters, the more important efficient logistics becomes in order to deal with both complexity and logistics costs. By involving proactive logistics from the start of retail internationalisation, retail chains can more efficiently and effectively establish into and operate within foreign sales markets, which in turn supports a sustainable retail internationalisation. One of the main academic contributions of this licentiate thesis has been to study logistics in the specific context of retail internationalisation, which has previously not been researched in any great detail. In addition, logistics has often been studied as a static aspect, but in this thesis it is studied from a dynamic perspective in order to understand how its supporting role changes over time during the early stage of retail internationalisation. Another important contribution is that the role of logistics has been studied from both a strategic and an operational level, as previous research has mostly focused on the strategic level of logistics related to retail internationalisation. In terms of practical contributions, this licentiate thesis clarifies the logistics characteristics and supply-chain capabilities that support the early stage of retail internationalisation. This licentiate thesis can also help practitioners to better prepare their logistics organisation and logistics operations for a future retail internationalisation, as well as helping them to avoid making logistical mistakes during the early stage of retail internationalisation.
Early Phase Drug Evaluation In Man
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Author : John O'Grady
language : en
Publisher: CRC Press
Release Date : 2020-02-03
Early Phase Drug Evaluation In Man written by John O'Grady and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-02-03 with Medical categories.
Early Phase Drug Evaluation in Man is a comprehensive, practical guide that covers pre-clinical information relevant to early human studies, including pharmaceutical, metabolic, toxicological, and regulatory aspects, as well as the general considerations relevant to all early human studies. Each major therapeutic area is considered by class of activity of drug. The chapters describe what measurements of drug activity are available in healthy human subjects and in patients, how to make the measurements, their value and their limitations. The contributors have been drawn internationally from the pharmaceutical industry and academia. Early Phase Drug Evaluation in Man will provide an important reference guide for industry and academic professionals involved in the development of new drugs.
Pre Milestone A And Early Phase Systems Engineering
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Author : National Research Council
language : en
Publisher: National Academies Press
Release Date : 2008-03-11
Pre Milestone A And Early Phase Systems Engineering written by National Research Council 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 2008-03-11 with Political Science categories.
The ability of U.S. military forces to field new weapons systems quickly and to contain their cost growth has declined significantly over the past few decades. There are many causes including increased complexity, funding instability, bureaucracy, and more diverse user demands, but a view that is gaining more acceptance is that better systems engineering (SE) could help shorten development time. To investigate this assertion in more detail, the US Air Force asked the NRC to examine the role that SE can play during the acquisition life cycle to address root causes of program failure especially during pre-milestone A and early program phases. This book presents an assessment of the relationship between SE and program outcome; an examination of the SE workforce; and an analysis of SE functions and guidelines. The latter includes a definition of the minimum set of SE processes that need to be accounted for during project development.
Novel Designs Of Early Phase Trials For Cancer Therapeutics
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Author : Shivaani Kummar
language : en
Publisher: Academic Press
Release Date : 2018-05-22
Novel Designs Of Early Phase Trials For Cancer Therapeutics written by Shivaani Kummar and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-05-22 with Medical categories.
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
Indicating Value In Early Stage Technology Venture Valuation
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Author : Christoph Philipp Wessendorf
language : en
Publisher: Springer Nature
Release Date : 2021-08-24
Indicating Value In Early Stage Technology Venture Valuation written by Christoph Philipp Wessendorf and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-08-24 with Business & Economics categories.
Fundraising for venture capital investments have continued to increase in recent years. One crucial step in the investment process is the valuation of the target company. Investors are faced with the great challenge of valuing a young venture without a corporate or financial history, a firm customer relationship or even a business model, while still taking into account the tremendous growth potential. Especially the valuation of technology companies is a difficult and often subjective process. Motivated by these considerations, this dissertation details a design science research project, which aims to develop an artifact that improves the indication of value in early-stage technology venture valuation while enabling operationalizable and fair valuation. This approach ensures a more meaningful valuation and better applicability to early-stage technology ventures compared to traditional methods while supporting the deliberate reduction of information asymmetries between entrepreneurs and investors. Firm-specific characteristics and practical applicability are taken into account.
Dose Finding Designs For Early Phase Cancer Clinical Trials
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Author : Takashi Daimon
language : en
Publisher: Springer
Release Date : 2019-05-21
Dose Finding Designs For Early Phase Cancer Clinical Trials written by Takashi Daimon and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-05-21 with Medical categories.
This book provides a comprehensive introduction to statistical methods for designing early phase dose-finding clinical trials. It will serve as a textbook or handbook for graduate students and practitioners in biostatistics and clinical investigators who are involved in designing, conducting, monitoring, and analyzing dose-finding trials. The book will also provide an overview of advanced topics and discussions in this field for the benefit of researchers in biostatistics and statistical science. Beginning with backgrounds and fundamental notions on dose finding in early phase clinical trials, the book then provides traditional and recent dose-finding designs of phase I trials for, e.g., cytotoxic agents in oncology, to evaluate toxicity outcome. Included are rule-based and model-based designs, such as 3 + 3 designs, accelerated titration designs, toxicity probability interval designs, continual reassessment method and related designs, and escalation overdose control designs. This book also covers more complex and updated dose-finding designs of phase I-II and I/II trials for cytotoxic agents, and cytostatic agents, focusing on both toxicity and efficacy outcomes, such as designs with covariates and drug combinations, maximum tolerated dose-schedule finding designs, and so on.
Early Phase Cancer Immunotherapy
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Author : Sandip Pravin Patel
language : en
Publisher: Springer
Release Date : 2017-11-03
Early Phase Cancer Immunotherapy written by Sandip Pravin Patel and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-11-03 with Medical categories.
This volume, a state-of-the-art review of early phase clinical trials for cancer immunotherapy, discusses biomarker selection, combinatorial strategies and their safety or toxicity, determination of Phase 2 dosing, endpoints in the setting of radiographic pseudoprogression, histology selection, and novel immunotherapeutics as they relate to early phase cancer immunotherapy.
Early Stage Breast Cancer New Developments And Controversies An Issue Of Surgical Oncology Clinics E Book
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Author : Eleftherios P. Mamounas
language : en
Publisher: Elsevier Health Sciences
Release Date : 2010-07-30
Early Stage Breast Cancer New Developments And Controversies An Issue Of Surgical Oncology Clinics E Book written by Eleftherios P. Mamounas and has been published by Elsevier Health Sciences this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-07-30 with Medical categories.
This issue of the Surgical Oncology Clinics will focus on new advances in Breast Cancer Surgery, and will include articles on Chemoprevention, Breast MRI, Genomics, Sentinel Node Biopsy, Extra-axillary Sentinel Nodes, Skin-Sparing and Nipple Sparing Mastectomy, Oncoplastic Techniques, Neoadjuvant Hormonal Therapy, Neoadjuvant Chemotherapy, Adjuvant Hormonal Therapy, Adjuvant Chemotherapy, and Biologic Targeted Therapies.