Biotechnology and safety assessment
نویسندگان
چکیده
منابع مشابه
[Agricultural biotechnology safety assessment].
Genetically modified (GM) crops were first introduced to farmers in 1995 with the intent to provide better crop yield and meet the increasing demand for food and feed. GM crops have evolved to include a thorough safety evaluation for their use in human food and animal feed. Safety considerations begin at the level of DNA whereby the inserted GM DNA is evaluated for its content, position and sta...
متن کاملEnvironmental safety assessment of vaccines derived from biotechnology.
Products derived from biotechnology are generally safer than previous products obtained by conventional, more empirical methods. Given the great variety of biotechnology-derived products and use situations, risk assessment procedures must be based on a case-by-case analysis. It is therefore difficult to propose a generic, well-defined risk assessment procedure. In the case of vectored vaccines,...
متن کاملSafety of Biotechnology Products
Medicines based on the application of recombinant technology are relatively new to the therapeutics industry. This chapter will focus specifically on purified and recombinant proteins, collectively termed protein therapeutic agents (Gallupi et al., 2001), used in the treatment of disease that are able to affect the growth or metabolism of cells in vivo. This rather broad definition includes pro...
متن کاملRisk assessment of biotechnology products
A number of crop products generated by using biotechnology have been introduced to the marketplace. These biotechnology products have been carefully evaluated for their overall safety from an agronomic, environmental, performance, and equivalence perspective, and the safety of the newly expressed protein(s). One aspect of the safety evaluation is the question concerning potential allergenicity....
متن کامل"Points to consider" regarding safety assessment of biotechnology-derived pharmaceuticals in non-clinical studies (English translation).
Regulatory and industrial scientists collaborated to publish a "points to consider" document regarding the safety assessment of biotechnology-derived pharmaceuticals in non-clinical studies in 2002 (Pharmaceutical Non-clinical Investigation Group, 2002). The collaboration team intended to clarify the interpretation of ICH-S6 guideline and furthermore share recent Japanese practices on this matt...
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ژورنال
عنوان ژورنال: Revista Brasileira de Ciências Farmacêuticas
سال: 2003
ISSN: 1516-9332
DOI: 10.1590/s1516-93322003000200013