Christopher P. Changelis Shayne Cox Gad Joseph F. Holson
This practical resource provides toxicologists and scientists with essential information on the regulations that govern their jobs and products. Regulatory Toxicology also covers the scientific and historical underpinnings of those regulations. Each chapter provides a grounding in the historical events that led to the development of original legislation and major subsequent changes in legislation. The major administrative divisions for regulatory agencies and their main missions and responsibilities are also detailed, as are the basic filing units or documents the agencies require of...
This practical resource provides toxicologists and scientists with essential information on the regulations that govern their jobs and products. Regul...
Choosing the right contract research organization (CRO) can make the difference between getting a product to market quickly and cost-effectively, and wasting valuable time and money. The myriad of CROs out there is increasing all the time, all making impressive claims. How do you pick the right one for your project? This guide for personnel in the pharmaceutical and medical device industries to making this important decision covers: guidance for selection, protocol and contract development, project management and monitoring of work; common pitfalls and problems - how to avoid them and how to...
Choosing the right contract research organization (CRO) can make the difference between getting a product to market quickly and cost-effectively, and ...
Purposefully designed as a resource for practicing and student toxicologists, Statistics and Experimental Design for Toxicologists and Pharmacologists, Fourth Edition equips you for the regular statistical analysis of experimental data. Starting with the assumption of basic mathematical skills and knowledge, the author supplies a complete and systematic yet practical introduction to the statistical methodologists available for, and used in, the discipline. For every technique presented, a worked example from toxicology is also presented. See what's new in the Fourth Edition: The first...
Purposefully designed as a resource for practicing and student toxicologists, Statistics and Experimental Design for Toxicologists and Pharmacologists...
Toxicology has made tremendous strides in the sophistication of the models used to identify and understand the mechanisms of agents that can harm or kill humans and other higher organisms. Non-animals or in vitro models started to gain significant use in the 1960s. As a result of the increased concern over animal welfare, economic factors, and the need for greater sensitivity and understanding of mechanisms, interest in in vitro models has risen. This volume demonstrates that there now exists a broad range of in vitro models for use in either identifying or understanding most forms of...
Toxicology has made tremendous strides in the sophistication of the models used to identify and understand the mechanisms of agents that can harm or k...
Best practices for conducting effective and safe clinical trials
Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials.
With contributions from a...
Best practices for conducting effective and safe clinical trials
Clinical trials are arguably the most important steps in proving drug effec...
A clear, straightforward resource to guide you through preclinical drug development
Following this book's step-by-step guidance, you can successfully initiate and complete critical phases of preclinical drug development. The book serves as a basic, comprehensive reference to prioritizing and optimizing leads, dose formulation, ADME, pharmacokinetics, modeling, and regulations. This authoritative, easy-to-use resource covers all the issues that need to be considered and provides detailed instructions for current methods and techniques.
Each chapter is written by one...
A clear, straightforward resource to guide you through preclinical drug development
Following this book's step-by-step guidance, you can ...
A comprehensive look at current drug discovery and development methods--and the roadmap for the future
Providing both understanding and guidance in characterizing potential drugs and their production and synthesis, Development of Therapeutic Agents Handbook gives professionals a basic tool to facilitate research and development within this challenging process. This comprehensive text brings together, in one resource, a compendium of concepts, approaches, methodologies, and limitations that need to be considered in the formulation of therapeutic agents across a range of...
A comprehensive look at current drug discovery and development methods--and the roadmap for the future
Biomaterials, Medical Devices, and Combination Products is a single-volume guide for those responsible for or concerned with developing and ensuring patient safety in the use and manufacture of medical devices.
The book provides a clear presentation of the global regulatory requirements and challenges in evaluating the biocompatibility and clinical safety of the materials used in producing medical devices as well as the devices themselves.
Starting with material characterization and selection, considerations of concerns arising from packaging and contact with production machinery,...
Biomaterials, Medical Devices, and Combination Products is a single-volume guide for those responsible for or concerned with developing and ensurin...
