ABSTRACT
The safety of therapeutic medicines is a global toxicology issue of the most obvious and longest-standing concern to the public. This chapter examines the regulations that establish how the safety of human pharmaceutical products are evaluated and established in the United States and the other major international markets. The 1906 law was designed to control blatantly misbranded and/or adulterated foods and drugs that relied on post-facto criminal charges for enforcement. A new drug substance means any substance that when used in the manufacture, processing or packaging of a drug causes that drug to be a new drug but does not include intermediates used in the synthesis of such substances. Antibiotics such as penicillin or doxorubicin are drugs derived from natural sources that have cytotoxic or cytostatic properties. Genetic toxicity testing generally focuses on the potential of a new drug to cause mutations or other forms of genetic damage.
