Reproduction and development are complex couple-dependent processes. Risk assessment for these health outcomes requires the use of biomarkers to link exposures to disease. Biological markers of susceptability, externa...Reproduction and development are complex couple-dependent processes. Risk assessment for these health outcomes requires the use of biomarkers to link exposures to disease. Biological markers of susceptability, external dose, internal dose, biologically effective dose, early or late biological responses, altered reproductive or developmental function, and reproductive or developmental disease are introduced. Using these biomarkers it is possible to define a biologically based risk assessment methodology for reproductive and developmental toxicity. Risk assessment for reproductive toxicity requires definition of male and female fecundity, couple-specific factors, spontaneous abortion, rate, and other factors. Using using sperm count as a biomarker for male fecundity, an example of a reproductive risk assessment using biomarkers is performed.展开更多
There are six large production institutes of bio-logicals in China. The Kunming Institute of Medical Biology is the largest primate center, specializing in the production of live poliomyelitis vaccine and recently, of...There are six large production institutes of bio-logicals in China. The Kunming Institute of Medical Biology is the largest primate center, specializing in the production of live poliomyelitis vaccine and recently, of live hepatitis vaccine as well. All these institutes have research laboratories of their own which are engaged in the improvement of existing products and development of new ones. The National Institute for Control of Phamaceutical and Biological Products, created in 1951, is responsible for the direction of laboratories located in each production institute, for the testing of natively produced as well as imported biological products and for the preparation and issuing of national standards. Three additional bodies managed directly by the Ministry of Public Health are: Office for the Review of Drugs (including biologicals), Committee for Standardization of Biological Products and Office for Supervision of Drugs. These together consistiute the regulatory system in China.展开更多
文摘Reproduction and development are complex couple-dependent processes. Risk assessment for these health outcomes requires the use of biomarkers to link exposures to disease. Biological markers of susceptability, external dose, internal dose, biologically effective dose, early or late biological responses, altered reproductive or developmental function, and reproductive or developmental disease are introduced. Using these biomarkers it is possible to define a biologically based risk assessment methodology for reproductive and developmental toxicity. Risk assessment for reproductive toxicity requires definition of male and female fecundity, couple-specific factors, spontaneous abortion, rate, and other factors. Using using sperm count as a biomarker for male fecundity, an example of a reproductive risk assessment using biomarkers is performed.
文摘There are six large production institutes of bio-logicals in China. The Kunming Institute of Medical Biology is the largest primate center, specializing in the production of live poliomyelitis vaccine and recently, of live hepatitis vaccine as well. All these institutes have research laboratories of their own which are engaged in the improvement of existing products and development of new ones. The National Institute for Control of Phamaceutical and Biological Products, created in 1951, is responsible for the direction of laboratories located in each production institute, for the testing of natively produced as well as imported biological products and for the preparation and issuing of national standards. Three additional bodies managed directly by the Ministry of Public Health are: Office for the Review of Drugs (including biologicals), Committee for Standardization of Biological Products and Office for Supervision of Drugs. These together consistiute the regulatory system in China.
