نتایج جستجو برای: approval of indications
تعداد نتایج: 21167475 فیلتر نتایج به سال:
BACKGROUND On the basis of noninferiority trials, tigecycline received Food and Drug Administration (FDA) approval in 2005. In 2010, the FDA warned in a safety communication that tigecycline was associated with an increased risk of death. METHODS PubMed, EMBASE, Scopus, and ClinicalTrials.gov were searched using the terms "tigecycline" and "randomized controlled trial (RCT)" through April 201...
The sixth comprehensive, evidence-based analysis of apheresis therapies by the American Society for Apheresis (ASFA) recorded 60 disease conditions as Category I (apheresis as first-line therapy) or Category II (apheresis as second-line or adjuvant therapy) indications for therapeutic apheresis. Among these, 37 (62%) were indications for plasma exchange, consistent with prior surveys that found...
OBJECTIVE To determine the incidence, indications, risk factors, and complications of emergency peripartum hysterectomy (EPH) and to evaluate total versus subtotal hysterectomy for EPH. MATERIALS AND METHODS This is a retrospective case series involving thorough examination of the files of all women who had EPH between January 2000 and December 2012 in the department of Obstetrics and Gynecol...
In "Replicating Milgram: Would People Still Obey Today?" Jerry M. Burger reported a high base rate of obedience, comparable to that observed by Stanley Milgram (1974). Another condition, involving a defiant confederate, failed to significantly reduce obedience. This commentary discusses the primary contributions of Burger's study in terms of (a) its novel methodological variation on Milgram's o...
The purposes of our study were to identify a drug entry process, collect, and prioritize criteria for selecting drugs for the list of basic health insurance commitments to prepare an "evidence based reimbursement eligibility plan" in Iran. The 128 noticeable criteria were found when studying the health insurance systems of developed countries. Four parts (involving criteria) formed the first qu...
Traditional drug licensing approaches are based on binary decisions. At the moment of licensing, an experimental therapy is presumptively transformed into a fully vetted, safe, efficacious therapy. By contrast, adaptive licensing (AL) approaches are based on stepwise learning under conditions of acknowledged uncertainty, with iterative phases of data gathering and regulatory evaluation. This ap...
Recent advances in biotechnology have led to discoveries resulting in major improvements in the therapy of refractory malignancies, although most advanced cancers remain incurable. Thus, there is global consensus around the need to streamline the drug approval process for effective agents. Accelerated Approval and Breakthrough Therapy Designation hold the promise of making new treatments availa...
In 2006, the European Medicines Agency (EMA) approved Omnitrope® as a biosimilar recombinant human growth hormone (rhGH), on the basis of comparable quality, safety, and efficacy to the reference medicine (Genotropin®, Pfizer). Data continue to be collected on the long-term efficacy of biosimilar rhGH from several on-going postapproval studies. Particular topics of interest include efficacy in ...
نمودار تعداد نتایج جستجو در هر سال
با کلیک روی نمودار نتایج را به سال انتشار فیلتر کنید