Healthy Skepticism Library item: 2500
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: Journal Article
Allen AJ, Michelson D.
Drug development process for a product with a primary pediatric indication.
J Clin Psychiatry 2002; 63:44-9
http://www.psychiatrist.com/pcc/pccpdf/v04s04/v63s1207.pdf
Abstract:
This article reviews the drug development process in the United States, focusing on practical issues and new U.S. Food and Drug Administration (FDA) regulations and guidance for developing a drug with a primary pediatric indication. Atomoxetine, a novel treatment for attention-deficit/ hyperactivity disorder (ADHD), is used to illustrate how the modern drug development process works and to highlight changes in the development of ADHD treatments since the introduction of the stimulants over 50 years ago. In addition to dealing with unique regulatory requirements and guidance, developing a drug for use in a pediatric population poses novel challenges in diverse areas including biomedical ethics, developmental pharmacology, and clinical trial design and implementation.
Keywords:
Antidepressive Agents/therapeutic use
Attention Deficit Disorder with Hyperactivity/drug therapy
Central Nervous System Stimulants/therapeutic use
Child
Clinical Trials/methods
Drug Approval/legislation & jurisprudence*
Drug Approval/methods
Drug Evaluation/legislation & jurisprudence*
Drug Evaluation/methods
Drug Evaluation/standards
Drug Industry/methods*
Drug Industry/standards
Drugs, Investigational/standards
Drugs, Investigational/therapeutic use*
Humans
Pediatrics/legislation & jurisprudence*
Propylamines/therapeutic use
United States
United States Food and Drug Administration*
*analysis
United States
FDA
Food and Drug Administration
Eli Lilly
industry perspective
clinical trials
children
ADHD
atomoxetine
off-label use
bioethics
PROMOTION IN SPECIFIC THERAPEUTIC AREAS: PSYCHIATRIC DISEASES
REGULATIONS, CODES, GUIDELINES: DIRECT GOVERNMENT REGULATION
