This specialty is offered to train students as experts in this professional field. After they have completed the courses of study required, they will be able to conduct research on and development of commercial products such as pharmaceuticals, foods, etc. using bioengineering technology. Their work will then also promote further growth and industrialization of the bioengineering field. To evaluate the efficacy and safety of new products, existing disciplines such as toxicology, toxicological pathology, safety pharmacology, laboratory animal science, environmental toxicology, and risk assessment must be applied. However, current training systems in the existing universities cannot produce appropriately trained scientists to fulfill the current requirements of the industry. Therefore, this specialty is expected to contribute greatly to the national supply of trained human resources, and thus to growth in industries concerned with the safety and efficacy of many products to which humans, animals and the environment are exposed. This will predictably lead predictably to increases in the quality of our national science and technology, as well as to our national welfare. The major objectives in preparing students for careers in this specialty will include training in the following subject areas, at minimum: 1. Fundamentals of toxicology, environmental toxicology, toxicological pathology, safety pharmacology, laboratory animal science, and related disciplines contributing to the assessment of efficacy and safety. 2. Basic skills and knowledge necessary to evaluate the physiologic and pharmacologic activities of new pharmaceutical candidates, allowing students to clearly understand their modes of actions on each organ or tissue. 3. Recent technologies and trends in the development of new pharmaceuticals, and how to evaluate efficacy of new pharmaceutical candidates. 4. Review of recently developed Living Modified Organism (LMO) products, the technologies required and used to evaluate their efficacy and their risks to humans and the environment. 5. Knowledge and skills necessary to evaluate and analyze the occupational health and safety of workers in the industry. 6. Administration and management of bioassays for the safety and efficacy of new products, to include Good Laboratory Practices (GLP) required to register new products. Careful analysis of test outcomes and incorporation of the test results in detailed reports are also included.