The Clinical Evaluation of a Food Additives

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.

Christian Tschanz, Harriett H. Butchko; W. Wayne Stargel; Frank N. Kotsonis

IntroductionRegulatory Requirements for Human Studies, J.P. Hile, C.K. Gund. B.L. Matos, and R.C. PetersonClinical Studies with Food Additives, W.W. Stargel, P.G. Sanders, C. Tschanz, and F.N. KotsonisThe Safety Assessment of Aspartame: Scientific and Regulatory Considerations, F.N. Kotsonis and J. HjelleAcceptable Daily Intake and Estimation of Consumption, H.H. Butchko and F.N. KotsonisMetabolism and Pharmacokinetic Studies in HumansMetabolism and Pharmacokinetics of Radiolabeled Aspartame in Normal Subjects, A. Karim and T. BurnsEffects of Aspartame Ingestion on Plasma Aspartate, Phenylalanine, and Methanol Concentrations in Normal Adults, L. D. Stegink and L.J. Filer, Jr.Effects of Aspartame Ingestion on Plasma Aspartate, Phenylalanine, and Methanol Concentrations in Potentially Sensitive Populations, L. D. Stegink and L.J. Filer, Jr.Safety Evaluation in Pregnancy, R.S. London and J.T. Rorick, Jr.Tolerance in Various PopulationsTolerance in Healthy Adults and Children, A.S. LeonTolerance in Individuals with Diabetes, J.W. Kolaczynski and J.F. CaroTolerance in PKU Heterozygotes, F.K. Trefz and H. BickelTolerance in Individuals with Renal Disease, G.U. Liepa and R.D. SmithTolerance in Individuals with Liver Disease, Z.I. Hertelendy and C.L. MendenhallEvaluation of Anecdotal Medical ComplaintsPostmarketing Surveillance of Anecdotal Medical Complaints, H.H. Butchko and C. TschanzEvaluation of Headaches, S.S. SchiffmanEvaluation of Seizures, G.M. Anderson, E.J. Novotny, Jr. and B.A. ShaywitzEvaluation of Behavior, Cognition, Mood, and Electroencephalograms in Normal Adults and Potentially Vulnerable Populations, D.L. Schomer, P. Spiers, and L.A. SabounjianEvaluation of Behavior, Cognition, and Electroencephalograms in PKU Heterozygotes, L.M.J. de Sonneville and C. BenningerEvaluation of Children with Attention Deficit Disorder, G.M. Anderson, S.E. Shaywitz, and B.A. ShaywitzEv