The Clinical Evaluation of a Food Additive: Assessment of Aspartame
Christian Tschanz, Harriett H. Butchko, W. Wayne Stargel, Frank N. Kotsonis
CRC Press, 25. jun. 1996 - 320 sider
This useful book reviews and analyzes the rigorous scientific, regulatory, and clinical testing and evaluation applied to the widely used food additive aspartame. In one compact volume you gain access to extensive information illustrating the increased recognition by regulatory agencies of the usefulness of human studies in evaluating new food additives.
The Clinical Evaluation of a Food Additive: Assessment of Aspartame begins by describing the nuts and bolts of food additive safety evaluation in humans, including an insightful historical perspective of the development of good clinical practice guidelines. It provides the regulatory requirements for human research, as well as key elements for the design and conduct of human studies. The scientific and regulatory considerations of food additive safety are explored, including interesting descriptions of aspartame's key animal safety studies. In addition, the book reviews the medical postmarketing surveillance system developed for identifying and evaluating reports of aspartame's alleged adverse health effects. Through meticulous research and systematic clarity, The Clinical Evaluation of a Food Additive: Assessment of Aspartame provides work-saving, state-of-the-art examples to guide future testing and evaluation of tomorrow's food additives.
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Scientific and Regulatory Considerations
Concentrations in Potentially Sensitive Populations
Safety Evaluation in Pregnancy
by CRC Press Inc 11
Postmarketing Surveillance of Anecdotal Medical Complaints
90th percentile adverse experiences animals aspartame and placebo aspartame consumption aspartame dose aspartame ingestion aspartame intake aspartame-sweetened beverage aspartic acid baseline behavior carbohydrate chronic Clin clinical study cognitive concentrations in normal consumed diabetes diet doses of aspartame Drug Administration effects of aspartame evaluated excretion food additive Food and Drug food intake G. D. Searle glucose headache hepatic encephalopathy heterozygous high mean plasma human increased individuals Kotsonis levels liver meal mean plasma phenylalanine metabolism methanol mg of aspartame mg/kg body weight mg/kg/day neurotransmitter neutral amino acids normal adults normal subjects Nutr patients Phe/LNAA phenylalanine hydroxylase phenylketonuria PKU heterozygotes placebo plasma amino acid plasma aspartate plasma concentrations plasma phenylalanine concentrations postmarketing surveillance postprandial potential protein rats renal reported safety seizures single bolus Stegink submitted by G. D. sucrose sweetener symptoms Teratogenic teratology Toxicol toxicology treatment tyrosine urine Wurtman