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Issues

Volume 104, Issue Supplement_3
1 September 1999
Issue Cover
ISSN 0031-4005
EISSN 1098-4275
In this Issue

The Therapeutic Orphan 30 Years Later

Supplement

Foreword
Sumner J. Yaffe, MD
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Topics: assault , clinical pharmacology , drug development , hungary , institute of medicine (u.s.)
Introduction
Jeffrey L. Blumer, PhD
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Topics: alabama , child health , climate , developmental biology , drug safety
Editorial Comment: Therapeutic Orphans
Harry Shirkey, MD
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Topics: orphan child
An Update on the Therapeutic Orphan
John T. Wilson, MD
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Topics: drugs, non-prescription , off-label use , united states food and drug administration , united states national institutes of health , united states pharmacopeia
Therapeutic Orphans: European Perspective
Baroukh M. Assael, MD
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Topics: orphan child , orphan drugs , pharmacy (field) , rare diseases
Is Pediatric Labeling Really Necessary?
Michael L. Christensen, PharmD; Richard A. Helms, PharmD; Russell W. Chesney, MD
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Topics: digoxin , disasters , food , infant, premature , medical literature
Off-Label Uses of Drugs in Children
Jeffrey L. Blumer, PhD
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Topics: off-label use
Essential Drugs for Infants and Children: North American Perspective
Ralph E. Kauffman, MD
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Topics: drugs, essential , united states food and drug administration
Essential Drugs for Infants and Children: European Perspective
Imti Choonara, MD
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Topics: drugs, essential
Lack of Pediatric Drug Formulations
Milap C. Nahata, PharmD
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Topics: dosage forms , drug formulation process , excipients , liquid dosage form
A Look at the Future of Pediatric Therapeutics: An Investigator's Perspective of the New Pediatric Rule
James D. Connor, MD
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Topics: anti-infective agents , chloramphenicol , drug development , fetus , government
European Regulatory Authorities and Pediatric Labeling
Elisabeth Autret, MD
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Topics: adverse effects , body weight , ethics , force of gravity , growth and development
Patient Recruitment: US Perspective
Philip D. Walson, MD
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Topics: ethics , institutional review board , patient recruitment , united states food and drug administration , economics
Patient Recruitment—European Perspective
Kalle Hoppu, MD
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Topics: antitussive agents , bronchodilator agents , cyclosporine , finnish , headache
Optimal Sampling Theory: An Overview of Its Application to Pharmacokinetic Studies in Infants and Children
Michael D. Reed, PharmD
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Topics: patient disposition , pharmacokinetics , accuracy , geographic population , drug concentration
Stable Isotopes Labeling of Drugs in Pediatric Clinical Pharmacology
Gerard Pons, MD; Elisabeth Rey, PharmD
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Topics: demethylation , isotopes , carbon dioxide , mass spectrometry
Phenotyping of Drug Metabolism in Infants and Children: Potentials and Problems
Anders Rane, MD
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Topics: cyp2c19 protein, human , cytochrome p-450 cyp2d6 , debrisoquin , drug metabolism , enzymes
The Pediatric Pharmacology Research Unit (PPRU) Network and Its Role in Meeting Pediatric Labeling Needs
Sanford N. Cohen, MD
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Topics: pediatric pharmacology , national institute of child health and human development
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