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Hi,
Could someone on this list point me to a reference on the declining
number of NDAs in the recent years despite increased spending in drug
development? The more recent the article, the better. It also needs to
be peer-reviewed and published in a scientific journal.
Thanks
Toufigh
Toufigh Gordi, PhD
Clinical Pharmacology, PK/PD analysis consultant
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Hi Toufigh
An overview of FDA drug approvals in recent years can be found in
Nature Reviews Drug Discovery; 2009; 8:93-96.
Regards,
Thomas Kakuda, Pharm.D.
Director, Clinical Pharmacology
Tibotec, Inc.
[Slide removed - db]
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Hi,
Here's one among many. You can also search the FDA website and look at
the critical path documents.
The impact of FDA and EMEA guidelines on drug development in relation
to Phase 0 trials.
http://www.ncbi.nlm.nih.gov/pubmed/17726450?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum
Marchetti S, Schellens JH.
Br J Cancer. 2007 Sep 3;97(5):577-81. Epub 2007 Aug 28. Review.
PMID: 17726450 [PubMed - indexed for MEDLINE]
Ahsan
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