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Author: Mark Chang
Publisher: CRC Press
ISBN: 1439835934
Category : Mathematics
Languages : en
Pages : 566
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Book Description
Helping you become a creative, logical thinker and skillful "simulator," Monte Carlo Simulation for the Pharmaceutical Industry: Concepts, Algorithms, and Case Studies provides broad coverage of the entire drug development process, from drug discovery to preclinical and clinical trial aspects to commercialization. It presents the theories and metho
Author: Mark Chang
Publisher: CRC Press
ISBN: 1439835934
Category : Mathematics
Languages : en
Pages : 566
Get Book Here
Book Description
Helping you become a creative, logical thinker and skillful "simulator," Monte Carlo Simulation for the Pharmaceutical Industry: Concepts, Algorithms, and Case Studies provides broad coverage of the entire drug development process, from drug discovery to preclinical and clinical trial aspects to commercialization. It presents the theories and metho
Author: Laura Brown
Publisher: Routledge
ISBN: 1317075137
Category : Business & Economics
Languages : en
Pages : 299
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Book Description
The pharmaceutical industry has encountered major shifts in recent years, both within the industry, and in its external environment. The cost of healthcare rising due to an ageing population, the intensification of regulatory requirements and mergers within the industry have led to an increased need for restructuring, cost reduction and culture change projects. Project management is the key to addressing these needs, and also to effective drug development. Given the costs of development and the critical issue of 'time to market', project management techniques - appropriately used - are a key factor in bringing a drug to market. In this book, Laura Brown and Tony Grundy's pharmaceutical expertise and experience offers the reader a guide to the most relevant project management tools and techniques and how to rigorously apply them in the pharmaceutical industry. The authors cover the technical, strategic and human aspects of project management, including contingency planning, simulation techniques and different project options. Complete with decision-tree diagrams, checklists, exercises and a full glossary, Project Management for the Pharmaceutical Industry provides clinical research, drug development and quality assurance managers or directors with a one-stop reference for successfully managing pharmaceutical projects. The text has been revised for this edition and now includes some additional material on risk management.
Author: Mr Tony Grundy
Publisher: Gower Publishing, Ltd.
ISBN: 140945908X
Category : Business & Economics
Languages : en
Pages : 299
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Book Description
The pharmaceutical industry has encountered major shifts in recent years, both within the industry, and in its external environment. The cost of healthcare rising due to an ageing population, the intensification of regulatory requirements and mergers within the industry have led to an increased need for restructuring, cost reduction and culture change projects. Project management is the key to addressing these needs, and also to effective drug development. Given the costs of development and the critical issue of 'time to market', project management techniques - appropriately used - are a key factor in bringing a drug to market. In this book, Laura Brown and Tony Grundy's pharmaceutical expertise and experience offers the reader a guide to the most relevant project management tools and techniques and how to rigorously apply them in the pharmaceutical industry. The authors cover the technical, strategic and human aspects of project management, including contingency planning, simulation techniques and different project options. Complete with decision-tree diagrams, checklists, exercises and a full glossary, Project Management for the Pharmaceutical Industry provides clinical research, drug development and quality assurance managers or directors with a one-stop reference for successfully managing pharmaceutical projects. The text has been revised for this edition and now includes some additional material on risk management.
Author: W. Messner
Publisher: Springer
ISBN: 1137340576
Category : Business & Economics
Languages : en
Pages : 263
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Book Description
Providing the necessary background information and hands-on tools to build compelling business cases, this book will increase the reader's capability to champion new business development ideas, take them to senior management, and facilitate the decision process by understanding the key theories and practices of finance and corporate investments.
Author: Mark Chang
Publisher: CRC Press
ISBN: 1498717470
Category : Mathematics
Languages : en
Pages : 226
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Book Description
All the Essentials to Start Using Adaptive Designs in No TimeCompared to traditional clinical trial designs, adaptive designs often lead to increased success rates in drug development at reduced costs and time. Introductory Adaptive Trial Designs: A Practical Guide with R motivates newcomers to quickly and easily grasp the essence of adaptive desig
Author: Harry Yang
Publisher: CRC Press
ISBN: 1498700357
Category : Mathematics
Languages : en
Pages : 259
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Book Description
Develop Effective Immunogenicity Risk Mitigation StrategiesImmunogenicity assessment is a prerequisite for the successful development of biopharmaceuticals, including safety and efficacy evaluation. Using advanced statistical methods in the study design and analysis stages is therefore essential to immunogenicity risk assessment and mitigation stra
Author: Ronald B. Geskus
Publisher: CRC Press
ISBN: 1466570369
Category : Mathematics
Languages : en
Pages : 278
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Book Description
Data Analysis with Competing Risks and Intermediate States explains when and how to use models and techniques for the analysis of competing risks and intermediate states. It covers the most recent insights on estimation techniques and discusses in detail how to interpret the obtained results.After introducing example studies from the biomedical and
Author: Oleksandr Sverdlov
Publisher: CRC Press
ISBN: 1482239892
Category : Mathematics
Languages : en
Pages : 536
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Book Description
Is adaptive randomization always better than traditional fixed-schedule randomization? Which procedures should be used and under which circumstances? What special considerations are required for adaptive randomized trials? What kind of statistical inference should be used to achieve valid and unbiased treatment comparisons following adaptive random
Author: Lyle D. Broemeling
Publisher: CRC Press
ISBN: 1482248204
Category : Mathematics
Languages : en
Pages : 556
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Book Description
Analyze Repeated Measures Studies Using Bayesian TechniquesGoing beyond standard non-Bayesian books, Bayesian Methods for Repeated Measures presents the main ideas for the analysis of repeated measures and associated designs from a Bayesian viewpoint. It describes many inferential methods for analyzing repeated measures in various scientific areas,
Author: Mai Zhou
Publisher: CRC Press
ISBN: 1466554932
Category : Mathematics
Languages : en
Pages : 221
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Book Description
Empirical Likelihood Method in Survival Analysis explains how to use the empirical likelihood method for right censored survival data. The author uses R for calculating empirical likelihood and includes many worked out examples with the associated R code. The datasets and code are available for download on his website and CRAN. The book focuses on all the standard survival analysis topics treated with empirical likelihood, including hazard functions, cumulative distribution functions, analysis of the Cox model, and computation of empirical likelihood for censored data. It also covers semi-parametric accelerated failure time models, the optimality of confidence regions derived from empirical likelihood or plug-in empirical likelihood ratio tests, and several empirical likelihood confidence band results. While survival analysis is a classic area of statistical study, the empirical likelihood methodology has only recently been developed. Until now, just one book was available on empirical likelihood and most statistical software did not include empirical likelihood procedures. Addressing this shortfall, this book provides the functions to calculate the empirical likelihood ratio in survival analysis as well as functions related to the empirical likelihood analysis of the Cox regression model and other hazard regression models.
