Background Lesions in Laboratory Animals will be an invaluable aid to pathologists needing to recognize background and incidental lesions while examining slides taken from laboratory animals in acute and chronic toxicity studies, or while examining exotic species in a diagnostic laboratory. It gives clear descriptions and illustrations of the majority of background lesions likely to be encountered. Many of the lesions covered are unusual and can be mistaken for treatment-related findings in preclinical toxicity studies. The Atlas has been prepared with contributions from experienced toxicological pathologists who are specialists in each of the laboratory animal species covered and who have published extensively in these areas. - over 600 high-definition, top-quality color photographs of background lesions found in rats, mice, dogs, minipigs, non-human primates, hamsters, guinea pigs and rabbits - a separate chapter on lesions in the reproductive systems of all laboratory animals written by Dr Dianne Creasy, a world expert on testicular lesions in laboratory animals - a chapter on common artifacts that may be observed in histological glass slides - extensive references to each lesion described - aging lesions encountered in all laboratory animal species, particularly in rats in mice which are used for carcinogenicity studies

Nonclinical Safety Assessment Nonclinical Safety Assessment A Guide to International Pharmaceutical Regulations Bringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty years, while necessary, has only served to amplify these costs. In response to this escalation, developmental strategies have shifted towards a more global approach. In order to create the most cost-effective and safe processes, it is critical for those bringing drugs to market to understand both the globally accepted regulations and the local variations. Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations provides a practical description of nonclinical drug development regulations and requirements in the major market regions. It includes: ICH – the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use National regulations, including US FDA, Canada, Mercosur and Brazil, South Africa, China, Japan, India and Australia Repeated dose toxicity studies Carcinogenicity; Genotoxicity; Developmental and reproductive toxicology; Immunotoxicology Biotechnology-derived pharmaceuticals Vaccine development Phototoxicity and photocarcinogenicity Degradants, impurities, excipients and metabolites Primarily intended for those professionals actively involved in the nonclinical and clinical development of a pharmaceutical product, including toxicologists, pharmacologists, clinicians and project managers, this book provides a roadmap for successful new drug approval and marketing.

This text provides a complete account of this particular rat strain. The book includes extensive data on reproductive indices, congenital abnormalities, growth, clinical signs, mortality, organ weights and chemical pathology. The data are derived from around 9000 control animals used in toxicology studies of two weeks to two years duration, completed between 1960 and 1992, and include 24 two-year studies and one life-span study of a 51 month duration. These extended periods of study have shown that many diseases are seen more frequently in later years.; Diseases are dealt with by body system and include clinical signs, macroscopic features and histopathology illustrations of the important or unusual diseases. Incidence levels are provided for all diseases and these are compared with published data for other rat strains.