Safety assessment program

Jaitly, R K., 1995, The CANDU-9 Probabilistic Safety Assessment Program, PSA 95, Seoul, Korea, pp 33-38, November 26-30. 

Erdal, B.R. Aguilar, R.D. Bayhurst, B.P. Daniels, W.R. Duffy, C.J. Lawrence, F.O. Maestas, S. Oliver, P.Q. Wolfsberg, K. "Sorption-Desorption Studies on Granite. I. Initial Studies of Strontium, Technetium, Cesium, Barium, Cerium, Europium, Uranium, Plutonium, and Americium", in "Proceedings of the Task 4 Waste Isolation Safety Assessment Program Second Contractor Information Meeting", Vol. II, Report PNL-SA-7352, Battelle Pacific Northwest Laboratory, 1978, pp. 7-67. 

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. 

There are other regulatory, legal and ethical safety assessment requirements beyond those involved in the selection and marketing of a drug as a product entity. The actual drug product must be manufactured and transported in a safe manner, and any waste associated with this manufacture disposed of properly Chapter 14 of this volume specifically addresses this often overlooked aspect of safety assessment programs. 

Additionally, the test materials used in the validation process should be as closely related as possible to the characteristics of the unknowns to be tested. It is clear from the literature, for instance, that many cytotoxicity assays give good correlations with the in vivo ocular irritancy data for surfactants, but the correlations fail when compounds from other chemical classes are tested. Since any particular assay may be used differently by individual safety assessment programs, users must evaluate potential methods under conditions likely to be encountered in their own situations. 

Rickert, P. G., Seitz, M. G., Fried, S. M., Friedman, A. M., and Steindler, M. J., "Transport Properties of Nuclear Waste in Geologic Media," report to the Waste Isolation Safety Assessment Program, March, ANL program code 85249-00 (1978). 

Types of Biopharmaceuticals Survey data on preclinical safety assessment programs were analyzed for 34 biopharmaceuticals cases. The numbers of antibodies, human proteins, and human protein analogues either in the development or marketed as of 2001 in Japan were 13,12, and 6, respectively. The remainder were bioconjugates, DNA-derived vaccines, and human T cell epitopes. Thus antibodies and human proteins are the two major biopharmaceuticals. 

The impact of the drug attributes of biopharmaceuticals on preclinical safety assessment programs for oncology products is not unique to this therapeutic area. As is true for all biopharmaceuticals, species cross-reactivity must be determined prior to selection of an appropriate animal model for safety evaluation. The nature of cross-reactivity can be based on a combination of phar-... 

The strategies to develop the preclinical safety assessment programs for biotechnology-derived therapeutics have often been characterized as case by... 

Safety pharmacology can be thought of as one of the key areas to be integrated with structural and biochemical evaluations in the complete safety assessment program (see scheme below). 

Mucciardi A. N. and Orr E. C. (1977) Statistical investigation of the mechanics controlling radionuclide sorption. In Waste Isolation Safety Assessment Program, Task 4, Contractor Information Meeting Proceedings. Battelle Northwest Laboratory, Richland, WA, pp. I5I-I88. 

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. 

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