This updated and expanded second edition provides practical guidance to people responsible for developing toxicology data, evaluating results from toxicology studies, and performing risk assessments. It will be particularly useful to those using outside laboratories to perform studies for regulatory submission.
Individuals charged with developing a safety profile on a new material may be nontoxicologists, inexperienced entry-level toxicologists, or toxicologists with expertise in a particular subdiscipline but lacking experience in other areas. Individuals with responsibility for assuring the safety of new products and materials are found in an array of businesses, including the pharmaceutical industry; biotechnology companies; medical device manufacturers; formulators of cosmetics and personal care products; herbal, food, and supplement companies; and the chemical, pesticide, and petroleum industries.
This text serves as a guide for proper study design to help ensure regulatory acceptance.
It addresses such issues as species selection, dose level and dosing regimen, animal number, routes of exposure, and proper statistical evaluation. Chapters focused on particular subdisciplines examine the purpose of the study, choice of species and the conditions under which the animals are maintained, experimental design, route of exposure, the duration of the study, choice of vehicles, and endpoints evaluated.
This second edition updates each chapter, with particular efforts made to add more help in data interpretation and hazard assessment. New chapters have been added to reflect changing regulatory requirements. These include chapters on safety pharmacology, juvenile studies, health safety assessment of pharmaceuticals, and heath assessment strategies in the food and cosmetic industry.
We have also included a separate and expanded chapter on carcinogenicity studies and the “good laboratory practices” chapter contains new information on how to evaluate the quality of a contract research organization prior to study placement.
The current business environment is dominated by downsized workforces, consolidated corporate functions, and lean start-ups. Often companies have a single individual responsible for all regulatory compliance issues. If that person has a background in toxicology at all, it is often general and cursory.