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.
Table of Contents
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