Project Description

Pharmaceuticals Company needs FDA GLP Preclinical Toxicology Laboratory for 90-day inhalation toxicity test (CFR 870.3465) in rats with special attention to histopathology (inflammation and cell proliferation) of the lung tissues and to various parameters of the bronchoalveolar lavage fluid (BALF), e.g., marker enzyme activities, total protein content, total cell count, cell differential, and cell viability. It is not necessary to look at internal organs. A recovery period of 60 days must be included to assess the progression or regression of any lesions.