Tobacco Clinical Trials
In the laboratory, chemical tests are conducted to assess the extent to which the level of toxicants from the new tobacco modified product will reduce as compared to the ordinary produced tobacco cigarettes, biological tests are also conducted to plot the early indication of whether the newly modified tobacco products provide assurance that the risk of harm will not be increased at an expense of other factors(Rees, et al., 2009). In practice, some of the laboratory testing methods and techniques has already been developed. Only the necessary amendments are required determine the effects of creating a new product ...view middle of the document...
, 2009). However, people may not consume or react to narcotic substances like machine. Therefore, clinical trials should establish whether toxicants are reduced when the same is tested by using the end products on real human users in the normal way.
Field testing should be conducted to assess whether the method used to insert salbutamol sulfate producing genes into tobacco plants is environmental friendly. Studies should be conducted in the soil to assess the effect of the new tobacco plant especially in places where crop rotation is practiced. These tests should also verify whether the new tobacco product can resist pests and maybe work on the possibility of transforming the new tobacco by introducing resistance genes into tobacco cells produced in tissue culture. Field tests also assess whether the modified tobacco plant will affect the disease resistance capability of conventional tobacco plant. Cross protection engineering viability especially to TMV infections is also assessed. This exercise involves inserting the TMV coat protein gene into the tobacco plant genome through the TI plasmid from A. tumefaciens(The Trustees of the University of Pennsylvania, 2009). This has also been carried out in other plants such as tomatoes engineering them to resist tomato mosaic virus and also alfalfa mosaic virus. This has suggested that many plants including tobacco can be engineered to produce viral disease resistant plants.
Clinical testing on the modified tobacco product should table arguments that are sufficiently compelling to support a conclusion that there is a scientific proof that there is a reduced exposure that is anticipated. Results from clinical or epidemiological studies should indicate measurable reduction in both mobility and mortality. Methods used to assess the reduced exposure of the new product should aid in determining likely patterns of human use and exposure(Tobacco Products Scientific Advisory Committee, 2012). The clinical trials should also provide insight into strategies that can be used to assess potential reduced products for the purpose of public health. The study report should document the...