1st Edition

The Clinical Evaluation of a Food Additives Assessment of Aspartame

    320 Pages
    by CRC Press

    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.

    Introduction
    Regulatory Requirements for Human Studies, J.P. Hile, C.K. Gund. B.L. Matos, and R.C. Peterson
    Clinical Studies with Food Additives, W.W. Stargel, P.G. Sanders, C. Tschanz, and F.N. Kotsonis
    The Safety Assessment of Aspartame: Scientific and Regulatory Considerations, F.N. Kotsonis and J. Hjelle
    Acceptable Daily Intake and Estimation of Consumption, H.H. Butchko and F.N. Kotsonis
    Metabolism and Pharmacokinetic Studies in Humans
    Metabolism and Pharmacokinetics of Radiolabeled Aspartame in Normal Subjects, A. Karim and T. Burns
    Effects 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 Populations
    Tolerance in Healthy Adults and Children, A.S. Leon
    Tolerance in Individuals with Diabetes, J.W. Kolaczynski and J.F. Caro
    Tolerance in PKU Heterozygotes, F.K. Trefz and H. Bickel
    Tolerance in Individuals with Renal Disease, G.U. Liepa and R.D. Smith
    Tolerance in Individuals with Liver Disease, Z.I. Hertelendy and C.L. Mendenhall
    Evaluation of Anecdotal Medical Complaints
    Postmarketing Surveillance of Anecdotal Medical Complaints, H.H. Butchko and C. Tschanz
    Evaluation of Headaches, S.S. Schiffman
    Evaluation of Seizures, G.M. Anderson, E.J. Novotny, Jr. and B.A. Shaywitz
    Evaluation of Behavior, Cognition, Mood, and Electroencephalograms in Normal Adults and Potentially Vulnerable Populations, D.L. Schomer, P. Spiers, and L.A. Sabounjian
    Evaluation of Behavior, Cognition, and Electroencephalograms in PKU Heterozygotes, L.M.J. de Sonneville and C. Benninger
    Evaluation of Children with Attention Deficit Disorder, G.M. Anderson, S.E. Shaywitz, and B.A. Shaywitz
    Evaluation of Allergic-Type Reactions, C. Ling, M. Zacks, and R.S. Geha
    Evaluation of Hunger, Food Intake, and Body Weight, B.J. Rolls and D.J. Shide
    Evaluation of Weight Control, B.S. Kanders, G.L. Blackburn, P.T. Lavin, and M. Kienholz
    Index

    Biography

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