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This Fourth Edition provides tools for the rigorous and critical analysis of experimental data. Assuming only basic mathematical skills, the book provides a complete and exhaustive introduction to the statistical methods available and updates all material to cover current practices. The book also provides three entirely new and up-to-the-minute chapters. One provides the first practical guide to performing meta analysis allowing for using the ...

This volume provides a complete update of all the materials in prior volumes on the subject (including current directories to testing labs and other support establishments worldwide), while adding substantial new material on the following topics: · The history of CROs, including snapshots of CROs and a genealogy chart making clear where they came from and where they went. · Study directors and principal investigators. · The nuts and bolt...

While the safety assessment ("biocompatibility") of medical devices has been focused on issues of local tissue tolerance (irritation, sensitization, cytotoxicity) and selected quantal effects (genotoxicity and acute lethality) since first being regulated in the late 1950s, this has changed as devices assumed a much more important role in healthcare and became more complex in both composition and in their design and operation.Add to this that d...

This volume provides a complete update of all the materials in prior volumes on the subject (including current directories to testing labs and other support establishments worldwide), while adding substantial new material on the following topics: · The history of CROs, including snapshots of CROs and a genealogy chart making clear where they came from and where they went. · Study directors and principal investigators. · The nuts and bolt...

While the safety assessment ("biocompatibility") of medical devices has been focused on issues of local tissue tolerance (irritation, sensitization, cytotoxicity) and selected quantal effects (genotoxicity and acute lethality) since first being regulated in the late 1950s, this has changed as devices assumed a much more important role in healthcare and became more complex in both composition and in their design and operation.Add to this that d...

This fourth edition provides tools for the rigorous and critical analysis of experimental data. Assuming only basic mathematical skills, the book provides a complete and exhaustive introduction to the statistical methods available and updates all material to cover current practices. The author also provides three entirely new and up-to-the-minute chapters: one provides the first practical guide to performing meta analysis that allows for the p...

Rev. ed. of: Safety pharmacology in pharmaceutical development and approval. c2004.

With three new chapters on Safety Data Sheet Preparation, Regulatory Requirements for GMOs, and Regulatory Requirements for Tobacco and Marijuana, this practical book provides toxicologists essential information on the regulations that govern their jobs and products. Each chapter covers the historical events that led to the original legislation.

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This practical resource provides all toxicologists and scientists with essential information on the regulations that govern the context and the content of their jobs and products.

Choosing the right contract research organization (CRO) can make the difference between getting a drug or medical device to market quickly and cost-effectively and wasting valuable time and money. This book provides guidelines for selection, protocol, and contract development, discusses project management and monitoring of work, explores how to integrate efforts between groups to achieve the greatest cost effectiveness while maintaining qualit...

Rev. ed. of: Safety pharmacology in pharmaceutical development and approval. c2004.

The last 10 years have seen a seismic shift in therapeutic product development and testing. In both the pharmaceutical (both small and large molecule) and medical device sectors, the vast majority of testing and evaluation of products is not performed within innovator companies, but rather has been outsourced to a growing universe of commercial organizations. The authors both have more than 30 years experience in this field, and both have work...

Keine Beschreibung.

The last 10 years have seen a seismic shift in therapeutic product development and testing. In both the pharmaceutical (both small and large molecule) and medical device sectors, the vast majority of testing and evaluation of products is not performed within innovator companies, but rather has been outsourced to a growing universe of commercial organizations. The authors both have more than 30 years experience in this field, and both have work...

Safety Evaluation of Pharmaceuticals and Medical Devices has been written to provide complete, ready and clear guidance as to what nonclinical safety assessment tests need to be performed to move a regulated therapeutic medical product into and through the development process and to marketing approval. This intent is purposely extended to cover the closely related product types of vaccines, biotechnology products, gene therapy, cell therapy, a...

Keine Beschreibung.

Safety Evaluation of Pharmaceuticals and Medical Devices has been written to provide complete, ready and clear guidance as to what nonclinical safety assessment tests need to be performed to move a regulated therapeutic medical product into and through the development process and to marketing approval. This intent is purposely extended to cover the closely related product types of vaccines, biotechnology products, gene therapy, cell therapy, a...