Carcinogenicity Testing: Factors, Overview, and Regulatory Guidelines

This report provides a comprehensive overview of carcinogenicity testing, a critical process in assessing the potential of substances, such as pharmaceuticals, to cause cancer. The report begins by defining carcinogens and their impact on cellular processes, emphasizing the importance of testing before the marketing of pharmaceuticals. It details various testing methods, including in vivo and cell culture studies, and highlights the factors considered in carcinogenicity testing, such as genetic toxicology, clinical dosage regimes, and pharmacologic dynamics. The report also references guidelines from organizations like ICH and OECD, and it discusses the evolving approaches to carcinogenicity studies, including the use of short-term and long-term studies. The conclusion underscores the significance of carcinogenicity testing in ensuring the safety of human treatment protocols and emphasizes the need for continued research and understanding in this field.