The Clinical Evaluation of a Food Additives: Assessment of Aspartame

ISBN-13: 9780849349737 / Angielski / Twarda / 1996 / 320 str.

Christian Tschanz; W. Wayne Stargel; Frank N. Kotsonis

Opis

This text looks at the scientific, regulatory and clinical testing and evaluation of aspartame. It illustrates the increasing recognition by regulatory agencies of the use of human studies in evaluating new food additives, and reviews how acceptable food additive daily intake levels are determined. Also covered are the clinical studies used to evaluate aspartame's anecdotal medical complaints, including headaches, seizures and allergic reactions.

Spis treści

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

O autorze

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