"Provides comprehensive, single-source coverage of the latest toxicity testing requirements and methods for personal care products, industrial and agricultural chemicals, and consumer goods. Second Edition, contains a new chapter on toxicokinetic testing and modeling, offers the latest solutions to common problems in testing and risk assessment, supplies an updated bibliography and more than 1300 references-over 100 new to this edition, and more."
"Provides comprehensive, single-source coverage of the latest toxicity testing requirements and methods for personal care products, industrial and agricultural chemicals, and consumer goods. Second Edition, contains a new chapter on toxicokinetic testing and modeling, offers the latest solutions to common problems in testing and risk assessment, supplies an updated bibliography and more than 1300 references-over 100 new to this edition, and more."
A practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug products Packaging and device components of Orally Inhaled and Nasal Drug Products (OINDP) such as metered dose inhalers, dry powder inhalers, and nasal sprays pose potential safety risks from leachables and extractables, chemicals that can be released or migrate from these components into the drug product. Addressing the concepts, background, historical use, and development of safety thresholds and their utility for qualifying leachables and extractables in OINDP, the Leachables and Extractables Handbook takes a practical approach to familiarize readers with the recent recommendations for safety and risk assessment established through a joint effort of scientists from the FDA, academia, and industry. Coverage includes best practices for the chemical evaluation and management of leachables and extractables throughout the pharmaceutical product life cycle, as well as: Guidance for pharmaceutical professionals to qualify and risk-assess container closure system leachables and extractables in drug products Principles for defining toxicological safety thresholds that are applicable to OINDP and potentially applicable to other drug products Regulatory perspectives, along with an appendix of key terms and definitions, case studies, and sample protocols Analytical chemists, packaging and device engineers, formulation development scientists, component suppliers, regulatory affairs specialists, and toxicologists will all benefit from the wealth of information offered in this important text.
Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in the design and analysis of safety studies are discussed with illustrative applications and examples. Medical Product Safety Evaluation: Biological Models and Statistical Methods presents cutting-edge biological models and statistical methods that are tailored to specific objectives and data types for safety analysis and benefit-risk assessment. Some frequently encountered issues and challenges in the design and analysis of safety studies are discussed with illustrative applications and examples. The book is designed not only for biopharmaceutical professionals, such as statisticians, safety specialists, pharmacovigilance experts, and pharmacoepidemiologists, who can use the book as self-learning materials or in short courses or training programs, but also for graduate students in statistics and biomedical data science for a one-semester course. Each chapter provides supplements and problems as more readings and exercises.
Using the detailed instructions in this book, readers will learn how to comply with product safety regulations, how to develop safe products, and how to implement safe manufacturing processes. In addition, readers will learn how to understand the federal regulations, determine how those regulations apply to their businesses, and understand the scope of their responsibilities.
A conmprehensive reference that blends theory with case studies from both the US and abroad to provide practical guidance on a variety of risk assessment and management strategies, which may be tailored to any particular company. The volume contains 18 chapters grouped into seven parts: overview and linkages (3 chapters); health (4 chapters); safety (2 chapters); ecology (3 chapters); international risk assessment (2 chapters); risk communication (2 chapters); and additional perspectives (2 chapters: industrial ecology and comprehensive risk assessment; and risk-based decision making--integrating risk management into business planning). Annotation copyright by Book News, Inc., Portland, OR
Drug Safety Evaluation presents an all-inclusive, practical guide for those who are responsible for ensuring the safety of drugs and biologics for patients, for health care providers, for those involved in the manufacture of medicinal products, and for all those who need to understand how the safety of these products is evaluated. Individual chapters address specific approaches to evaluating hazards, including problems that are encountered and their solutions. Author Shayne Gad draws upon over twenty years of experience in toxicology, drug development, and risk assessment, explaining the scientific and philosophical bases for evaluating specific concerns (carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching new problems. Containing information specifically relevant to the pharmaceutical and biotechnology industries, Drug Safety Evaluation covers a wide variety of topics, including: Acute toxicity testing in pharmaceutical safety evaluation Genotoxicity Safety assessment of inhalant drugs Immunotoxicology in pharmaceutical development Large animal studies Evaluation of human tolerance and safety in clinical trials Drug Safety Evaluation provides a road map for safety assessment as an integral part of the development of new drugs and therapeutics.
The Security Risk Assessment Handbook: A Complete Guide for Performing Security Risk Assessments provides detailed insight into precisely how to conduct an information security risk assessment. Designed for security professionals and their customers who want a more in-depth understanding of the risk assessment process, this volume contains real-wor
