منابع مشابه
Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study
OBJECTIVE To evaluate the use of special expedited development and review pathways at the US Food and Drug Administration over the past two decades. DESIGN Cohort study. SETTING FDA approved novel therapeutics between 1987 and 2014. POPULATION Publicly available sources provided each drug's year of approval, their innovativeness (first in class versus not first in class), World Health Org...
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Patients with hormone-sensitive breast cancer who have responded to tamoxifen may receive additional benefit from a second endocrine agent following progression or relapse after tamoxifen therapy. Fulvestrant (Faslodex((R)), ICI 182780, AstraZeneca Pharmaceuticals; Wilmington, Delaware) is a selective antagonist of estrogen designed to have no estrogenic effects. Lack of aqueous solubility led ...
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The purpose of this report is to summarize information on oxaliplatin, a drug recently approved by the U.S. Food and Drug Administration. Information provided includes regulatory history, study design, efficacy and safety results, and pertinent literature references. A single, multicenter, randomized trial, enrolling 463 patients with metastatic colorectal carcinoma whose disease had recurred o...
متن کاملMining FDA drug labels for medical conditions
BACKGROUND Cincinnati Children's Hospital Medical Center (CCHMC) has built the initial Natural Language Processing (NLP) component to extract medications with their corresponding medical conditions (Indications, Contraindications, Overdosage, and Adverse Reactions) as triples of medication-related information ([(1) drug name]-[(2) medical condition]-[(3) LOINC section header]) for an intelligen...
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Actavis and Adamas Pharmaceuticals, Inc., announced that the U.S. Food and Drug Administration has approved the New Drug Application for NamzaricTM for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on memantine hydrochloride and donepezil hydrochloride. Namzaric will be available in two dosage strengths: 28/10 mg (memantine extended release/donepezi...
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ژورنال
عنوان ژورنال: Journal of Pharmacovigilance
سال: 2016
ISSN: 2329-6887
DOI: 10.4172/2329-6887.1000e156