Toxicology assessment programs

Although prediction of ADME/PK in man may be the primary purpose for the pre-clinical studies, it is also important that potential new drugs have acceptable properties in toxicology species. Without these it can be very difficult to generate adequate safety margins to allow studies in man to start. It is also likely that the development safety assessment program will be difficult and hence slow. 

Extension Toxicology Network (EXTOXNET). 1996, June (revised). Diuron. Pesticide Information Profiles. A Pesticide Information Project of Cooperative Extension Offices of Cornell University, Oregon State University, the University of Idaho, and the University of California at Davis and the Institute for Environmental Toxicology, Michigan State University USDA/Extension Service/National Agricultural Pesticide Impact Assessment Program, http //extoxnet.orst.edu/pips/diuron.htm (accessed May 8, 2006). 

CRITICAL ASSESSMENT OF THE METHOD As stated earlier, this method has lost importance because for the development of a drag to be clinically administered i.v. the toxicological testing program should... 

Increasingly, alternative models that use other than intact higher organisms are being used in toxicology for a number of reasons. These reasons include desires for specificity of response, use of small quantities of test materials, and expedited development, all of which are particularly important in the biotechnology industries. Well-reasoned use of in vitro or other alternative test model systems is essential to the development of a product safety assessment program that is both effective and efficient. 

High Production Volume (HPV) Challenge is a program defined in 1998 by the EPA for toxicological assessment of substances that are manufactured or imported into the United States. 

Crump, K. S., Howe, R. B., Van Landingham, C., and Fuller, W. G. (1991). TOXRISK Version 3. Toxicology RISK Assessment Program. KS Crump Division, Clement Intemahonal Division, 1201 Gaines Street, Ruston, LA 71270. 

Carol A. Maczka, Director, Toxicology and Risk Assessment Program... 

The committee is grateful for the assistance of the NRC staff in preparing the report. Staff members who contributed to this effort are Carol A. Maczka, senior program director for the Toxicology and Risk Assessment Program Michelle Catlin, research associate Ruth E. Crossgrove, editor Laura Holliday and Judy Estep, senior project assistants and Mirsada Karalic-Loncarevic, information specialist. 

Section 104(i)(5) of CERCLA, as amended, directs the Administrator of ATSDR (in consultation with the Administrator of EPA and agencies and programs of the Public Health Service) to assess whether adequate information on the health effects of methyl parathion is available. Where adequate information is not available, ATSDR, in conjunction with the National Toxicology Program (NTP), is required to assure the initiation of a program of research designed to determine the health effects (and techniques for developing methods to determine such health effects) of methyl parathion. 

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