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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.
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 Subject :AAP’s Guidelines for the Ethical Conduct of Studies to Evaluate Drug.. 2010-05-13 22:55:29 
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Subject :AAP’s Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Population

Dear Friends,
 
Please find attached American Academy of Pediatrics’ Clinical Report—Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations.
 
The proper ethical conduct of studies to evaluate drugs in children is of paramount importance to all those involved in these types of studies. This report is an updated revision to the previously published guidelines from the American Academy of Pediatrics in 1995. Since the previous publication, there have been great strides made in the science and ethics of studying drugs in children. There have also been numerous legislative and regulatory advancements that have promoted the study of drugs in children while simultaneously allowing for the protection of this particularly vulnerable group. This report summarizes these changes and advances and provides a framework from which to guide and monitor the ethical conduct of studies to evaluate drugs in children.
 
Kind regards,


Attachments
 Ethical Gudelines for Clinical Trials_Paediatrics.pdf [102 KB] ::
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Last Edited On: 2010-05-13 22:55:29 By GCP HelpDesk for the Reason
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