ライフサイエンスコーパス: orphan drug

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1 Since the introduction of the Orphan Drug Act in 1983, designed to promote development

2 The Orphan Drug Act incentivizes medication development for

3 e leveraged the incentivized benefits of the Orphan Drug Act to develop more of these drugs for orpha

4 NMEs and for 73% of non-orphan versus 45% of orphan drug approvals.

5 grouped by product category, review status, orphan-drug designation and therapeutic indication, and

6 igh share of FDA priority review ratings, of orphan drug designations at approval, and of drugs that

7 As orphan drug development grows, demand will likely increa

8 function, we investigated the effect of the orphan drug dichloroacetate (DCA) on survival in an anim

9 drugs, pivotal trials for recently approved orphan drugs for cancer were more likely to be smaller a

10 US Food and Drug Administration has approved orphan drugs for neurological diseases without randomize

11 The concept of orphan drugs for treatment of orphan genetic diseases is

12 bitor that has been recently approved as an 'orphan drug' for the treatment of patients with unresect

13 Pivotal trials of orphan drugs had smaller participant numbers (median, 96

14 f treatments for rare diseases, at least 378 orphan drugs have been approved.

15 We created the orphan drug Human Botulism Immune Globulin Intravenous (

16 s for AA for oncology NMEs, particularly for orphan drug indications, may facilitate timely FDA appro

17 y to be completed for orphan drug versus non-orphan drug indications.

18 tion is the target of the recently approved 'orphan drug', ivacaftor.

19 First in class, priority review, fast track, orphan drug, or accelerated approval status was retrieve

20 manent with special incentives for pediatric orphan drug-product development.

21 rug discovery offering a promising venue for orphan drug research.

22 rials respectively and NeuroSTAT(R) received orphan drug status from US FDA and Europe in 2010.

23 We reviewed data on orphan drug status, development time, safety, and status

24 for amebiasis, and the drug has been granted orphan-drug status from the FDA.

25 f recently approved, novel, mutation guided 'orphan drug' therapies that have established clinical be

26 re nine-fold less likely to be completed for orphan drug versus non-orphan drug indications.

27 ents had serious adverse events in trials of orphan drugs vs trials of nonorphan drugs (48% vs 36%; o

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