Specification changes, reporting

Pathological changes reported to occur in the BN rat are not unique to any one compound and include both organ-specific (glomerulonephritis, splenomegaly, skin rashes) and systemic effects (hyperimmunoglobulinemia, in particular IgE, and increased levels of autoantibodies) and is accompanied by polyclonal T and B cell lymphopro-liferation [17, 18],... 

Genetic tests are performed on a sample of blood, hair, skin, amniotic fluid (the fluid that surrounds a fetus during pregnancy), or other tissue. For example, a procedure called a buccal smear uses a small brush or cotton swab to collect a sample of cells from the inside surface of the cheek. The sample is sent to a laboratory where technicians look for specific changes in chromosomes, DNA, or proteins, depending on the suspected disorder. The laboratory reports the test results in writing to a person s doctor or genetic counselor. 

For amendments, supplements, and annual reports, either the cover letter or the narrative for the section that was changed by the new submission should contain a description of the specific changes to previously submitted material. A comparison between the new information and the old information is preferred. 

An extensive NMR study of various 1 4-linked disaccharides with D- and L- monosaccharides mixed in disaccharides has been reported [66]. Each group of disaccharides exhibits specific changes in chemical shifts due to glycosidations of the C-4 hydroxy group, which are different between the groups. The differences in chemical shifts were correlated to the preferred conformations of the disaccharides and used to predict the and NMR chemical shifts of 1 4-linked oligo- and polysaccharides. 

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