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

Please
Click to Register

(read more)

then
Log in
for free access to more features of this website.

Forgot your username or password?

You are invited to
apply for membership
of Healthy Skepticism,
if you support our aims.

Pay a subscription

Support our work with a donation

Buy Healthy Skepticism T Shirts

If there is something you don't like, please tell us. If you like our work, please tell others.

Announcements

PharmedOut’s annual conference: Missing The Target: When Practitioners Harm More Than Heal

No Free Lunch is merging with Healthy Skepticism

Conference program: Pharma Knows Best? Managing Medical Knowledge

Prescrire’s proposals for France’s national conference on medicines policy

Pharmed Out Conference ‘Pharma Knows Best? Managing Medical Knowledge’

More announcements

What's new on this site

Library Home

Library Search

Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909