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This useful book reviews and analyzes the rigorous scientific, regulatory, and clinical testing and evaluation applied to the widely used food additive aspartame. It 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 guidel
This useful book reviews and analyzes the rigorous scientific, regulatory, and clinical testing and evaluation applied to the widely used food additive aspartame. It 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 guidel
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Autorenporträt
Christian Tschanz, Harriett H. Butchko; W. Wayne Stargel; Frank N. Kotsonis
Inhaltsangabe
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
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
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