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Efficient Trial Design — FDA Approval of Valbenazine for Tardive Dyskinesia
- Source :
- New England Journal of Medicine. 376:2503-2506
- Publication Year :
- 2017
- Publisher :
- Massachusetts Medical Society, 2017.
-
Abstract
- In the case of valbenazine, which was recently approved for tardive dyskinesia, a small company pursued thoughtful, efficient trial design and an unusual application of remote assessment in clinical trials, and the FDA took an engaged and flexible approach to review.
- Subjects :
- medicine.medical_specialty
Dopamine
Tetrabenazine
Tardive dyskinesia
Synaptic Transmission
03 medical and health sciences
0302 clinical medicine
medicine
Drug approval
Humans
Tardive Dyskinesia
Medical physics
Valbenazine
030212 general & internal medicine
Psychiatry
Dopamine metabolism
Drug Approval
United States Food and Drug Administration
business.industry
Fda approval
Valine
General Medicine
medicine.disease
United States
Clinical trial
Clinical research
Clinical Trials, Phase III as Topic
Vesicular Monoamine Transport Proteins
business
030217 neurology & neurosurgery
Antipsychotic Agents
Subjects
Details
- ISSN :
- 15334406 and 00284793
- Volume :
- 376
- Database :
- OpenAIRE
- Journal :
- New England Journal of Medicine
- Accession number :
- edsair.doi.dedup.....3e26dee515f22eed521d7a0ecd3af4e3