The Clinical Evaluation of a Food Additives: Assessment of Aspartame, 1st Edition (Hardback) book cover

The Clinical Evaluation of a Food Additives

Assessment of Aspartame, 1st Edition

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

CRC Press

320 pages

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Hardback: 9780849349737
pub: 1996-06-25
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Description

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

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

Subject Categories

BISAC Subject Codes/Headings:
TEC012000
TECHNOLOGY & ENGINEERING / Food Science