Bøger i Pharmaceutical Development Series serien

Provides a comprehensive and thorough reference on the basics and practices of clinical trials Includes chapters on hot topics like: adverse event reporting (AER) systems, adaptive trial designs, and crossover trial designs Presents chapters on issues for specific disease areas: cardiology, oncology, cognitive, dermatology, etc.

This book gives the professional pharmaceutical scientist a basic and comprehensive tool to facilitate the preclinical development process by bringing together an overview of the preclinical process and a compendium of methods and techniques that need to be considered when developing a new drug.

This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system.

This book provides drug safety and toxicology scientists with practical guidance for testing and determining the effectiveness and safety of a new drug candidate. It authoritatively covers the important topics within toxicity testing, pharmacogenomics, and regulations for the preclinical safety testing of drug candidates.

With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing.

This book brings together in one resource an overview of the preclinical process along with a compendium of methods and techniques that need to be considered when developing a new drug.

This book is a one-stop compendium of up-to-date concepts, approaches, methodologies, and limitations in drug development and therapeutics. It provides researchers with a thorough reference focusing on applications, practical methods, and techniques to facilitate new drug development.

This new edition of Drug Safety Evaluation offers a practical guide presents a road map for both the performance and evaluation of safety assessment as an integral part of the development of new drugs and therapeutics.

Pharmaceutical Manufacturing Handbook covers a range of topics to help professionals better understand the methods used in the pharmaceutical manufacturing, pharmaceutical engineering, and process engineering fields.