Intended as a tool for use by public health officials, research and regulatory scientists and risk managers, this publication seeks to provide a scientific framework for the use and interpretation of reproductive toxicity data from human and animal studies. It also discusses emerging methodology and testing strategy in reproductive toxicity. The text focuses on approaches to assessing reproductive toxicity in males and females, including sexual dysfunction and infertility, and many aspects of developmental toxicity (following both prenatal and postnatal exposure), from conception to sexual maturation. It is an overview of the major scientific principles underlying hazard identification, testing methods and risk assessment strategies in human reproductive toxicity. It also discusses the evaluation of reproductive toxicity data in the context of the extensive risk assessment methodology that has emerged over the past 10-15 years.

Conclusions, and recommendations -- Introduction and background -- Unique biological characteristics of children -- Developmental stage-specific susceptibilities and outcomes in children -- Exposure assessment of children -- Methodologies to assess health outcomes in children -- Implications and strategies for risk assessment for children.

Published under the International Programme for Chemical Safety (IPCS), a joint venture of UNEP, ILO and the WHO

This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

This is a reference for those who need to understand the fundamental toxicological concepts that underlie both the scientific development of the subject and its practical applicaton in regulation and management of chemical safety.

The International Life Sciences Institute (!LSI) is a scientific foundation that addresses critical health and safety issues of national and international con cern. ILSI promotes international cooperation by providing the mechanism for scientists from government, industry, and universities to work together on cooperative programs to generate and disseminate scientific data. The mem bers and trustees of the institute believe that questions regarding health and safety are best resolved when scientists can examine and discuss issues as an independent body separate from the political pressures of individual countries and the economic concerns of individual companies. Frequently, meaningful assessment of the risk of a test substance is hindered by the inherent inconsistencies in the system. The development and refine ment of methods and systems to evaluate the safety of chemicals have evolved in a rapid and largely unplanned fashion. Attempts to improve the system have mainly been directed toward broad general concerns, with little attention being given to specific problems or issues. A failure to resolve these problems has frequently resulted in increased testing costs and complications in the assessment and extrapolation of the results to humans. Publicity surrounding toxicologic issues makes it difficult for governments to deal effectively with these problems. In response to these difficulties, ILSI has assembled highly qualified and renowned scientists from research institutes, universities, government, and industry with relevant scientific knowledge and expertise regarding the issues that complicate risk assessment procedures.