Author: United States. Food and Drug Administration. Science Advisory Board
Publisher:
ISBN:
Category : Antibiotics
Languages : en
Pages : 22
Book Description
National Antimicrobial Resistance Monitoring System (NARMS) Program Review
Author: United States. Food and Drug Administration. Science Advisory Board
Publisher:
ISBN:
Category : Antibiotics
Languages : en
Pages : 22
Book Description
Publisher:
ISBN:
Category : Antibiotics
Languages : en
Pages : 22
Book Description
NARMS-TAC 2002
Author: Reginald Hammah
Publisher:
ISBN:
Category : Mining engineering
Languages : en
Pages : 1030
Book Description
Publisher:
ISBN:
Category : Mining engineering
Languages : en
Pages : 1030
Book Description
FDA Consumer
Innovative Strategies, Statistical Solutions and Simulations for Modern Clinical Trials
Author: Mark Chang
Publisher: CRC Press
ISBN: 1351214535
Category : Mathematics
Languages : en
Pages : 362
Book Description
"This is truly an outstanding book. [It] brings together all of the latest research in clinical trials methodology and how it can be applied to drug development.... Chang et al provide applications to industry-supported trials. This will allow statisticians in the industry community to take these methods seriously." Jay Herson, Johns Hopkins University The pharmaceutical industry's approach to drug discovery and development has rapidly transformed in the last decade from the more traditional Research and Development (R & D) approach to a more innovative approach in which strategies are employed to compress and optimize the clinical development plan and associated timelines. However, these strategies are generally being considered on an individual trial basis and not as part of a fully integrated overall development program. Such optimization at the trial level is somewhat near-sighted and does not ensure cost, time, or development efficiency of the overall program. This book seeks to address this imbalance by establishing a statistical framework for overall/global clinical development optimization and providing tactics and techniques to support such optimization, including clinical trial simulations. Provides a statistical framework for achieve global optimization in each phase of the drug development process. Describes specific techniques to support optimization including adaptive designs, precision medicine, survival-endpoints, dose finding and multiple testing. Gives practical approaches to handling missing data in clinical trials using SAS. Looks at key controversial issues from both a clinical and statistical perspective. Presents a generous number of case studies from multiple therapeutic areas that help motivate and illustrate the statistical methods introduced in the book. Puts great emphasis on software implementation of the statistical methods with multiple examples of software code (both SAS and R). It is important for statisticians to possess a deep knowledge of the drug development process beyond statistical considerations. For these reasons, this book incorporates both statistical and "clinical/medical" perspectives.
Publisher: CRC Press
ISBN: 1351214535
Category : Mathematics
Languages : en
Pages : 362
Book Description
"This is truly an outstanding book. [It] brings together all of the latest research in clinical trials methodology and how it can be applied to drug development.... Chang et al provide applications to industry-supported trials. This will allow statisticians in the industry community to take these methods seriously." Jay Herson, Johns Hopkins University The pharmaceutical industry's approach to drug discovery and development has rapidly transformed in the last decade from the more traditional Research and Development (R & D) approach to a more innovative approach in which strategies are employed to compress and optimize the clinical development plan and associated timelines. However, these strategies are generally being considered on an individual trial basis and not as part of a fully integrated overall development program. Such optimization at the trial level is somewhat near-sighted and does not ensure cost, time, or development efficiency of the overall program. This book seeks to address this imbalance by establishing a statistical framework for overall/global clinical development optimization and providing tactics and techniques to support such optimization, including clinical trial simulations. Provides a statistical framework for achieve global optimization in each phase of the drug development process. Describes specific techniques to support optimization including adaptive designs, precision medicine, survival-endpoints, dose finding and multiple testing. Gives practical approaches to handling missing data in clinical trials using SAS. Looks at key controversial issues from both a clinical and statistical perspective. Presents a generous number of case studies from multiple therapeutic areas that help motivate and illustrate the statistical methods introduced in the book. Puts great emphasis on software implementation of the statistical methods with multiple examples of software code (both SAS and R). It is important for statisticians to possess a deep knowledge of the drug development process beyond statistical considerations. For these reasons, this book incorporates both statistical and "clinical/medical" perspectives.
Agriculture, Rural Development, and Related Agencies Appropriations for Fiscal Year 2003
Author: United States. Congress. Senate. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, and Related Agencies
Publisher:
ISBN:
Category : Political Science
Languages : en
Pages : 854
Book Description
Publisher:
ISBN:
Category : Political Science
Languages : en
Pages : 854
Book Description
Antimicrobial Resistance and Food Safety
Author: Chin-Yi Chen
Publisher: Elsevier
ISBN: 0128013370
Category : Technology & Engineering
Languages : en
Pages : 457
Book Description
Antimicrobial Resistance and Food Safety: Methods and Techniques introduces antimicrobial resistant food-borne pathogens, their surveillance and epidemiology, emerging resistance and resistant pathogens. This analysis is followed by a systematic presentation of currently applied methodology and technology, including advanced technologies for detection, intervention, and information technologies. This reference can be used as a practical guide for scientists, food engineers, and regulatory personnel as well as students in food safety, food microbiology, or food science. Includes analysis of all major pathogens of concern Provides many case studies and examples of fundamental research findings Presents recent advances in methodologies and analytical software Demonstrates risk assessment using information technologies in foodborne pathogens
Publisher: Elsevier
ISBN: 0128013370
Category : Technology & Engineering
Languages : en
Pages : 457
Book Description
Antimicrobial Resistance and Food Safety: Methods and Techniques introduces antimicrobial resistant food-borne pathogens, their surveillance and epidemiology, emerging resistance and resistant pathogens. This analysis is followed by a systematic presentation of currently applied methodology and technology, including advanced technologies for detection, intervention, and information technologies. This reference can be used as a practical guide for scientists, food engineers, and regulatory personnel as well as students in food safety, food microbiology, or food science. Includes analysis of all major pathogens of concern Provides many case studies and examples of fundamental research findings Presents recent advances in methodologies and analytical software Demonstrates risk assessment using information technologies in foodborne pathogens
Agriculture, Rural Development, and Related Agencies Appropriations for Fiscal Year 2006
Author: United States. Congress. Senate. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, and Related Agencies
Publisher:
ISBN:
Category : Political Science
Languages : en
Pages : 564
Book Description
Publisher:
ISBN:
Category : Political Science
Languages : en
Pages : 564
Book Description
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2006, Part 1B, 109-1 Hearings,*
Agriculture, Rural Development, and Related Agencies Appropriations for Fiscal Year 2002
Author: United States. Congress. Senate. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, and Related Agencies
Publisher:
ISBN:
Category : United States
Languages : en
Pages : 986
Book Description
Publisher:
ISBN:
Category : United States
Languages : en
Pages : 986
Book Description
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2015
Author: United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Publisher:
ISBN:
Category : United States
Languages : en
Pages : 1096
Book Description
Publisher:
ISBN:
Category : United States
Languages : en
Pages : 1096
Book Description