نتایج جستجو برای: fda criteria
تعداد نتایج: 273287 فیلتر نتایج به سال:
Drug development involves the chemical identification and characterization of a compound to determine stability and define the drug's preliminary actions. Preclinical research follows in animals to develop a pharmacokinetic profile to determine dose range, biotransformation, elimination, and toxicology. The 4 phases of clinical research, phase 1 to phase 4, encompass a progressive investigation...
BACKGROUND On 30 January 2012, the US FDA approved vismodegib (Erivedge®, Genentech, CA, USA) for the management of both metastatic and locally advanced basal cell carcinoma. OBJECTIVE Our objective was to identify evidence of hepatotoxicity with vismodegib in the FDA Adverse Event Reporting System (FAERS) in treated patients in two National Cancer Institute Comprehensive Cancer Centers. ME...
n engl j med 370;11 nejm.org march 13, 2014 985 of things about your health,” including that you “might have an increased risk of heart disease, arthritis, gallstones, [or] hemochromatosis” (www.ispot.tv/ad/7qoF/ 23-and-me). It was the centerpiece of the company’s campaign to sign up 1 million consumers. On November 22, the Food and Drug Administration (FDA) sent 23andMe a warning letter orderi...
BACKGROUND The Kineflex lumbar artificial disc replacement device (SpinalMotion, Mountain View, California) is a semiconstrained, posterior center of rotation, metal-on-metal intervertebral disc prosthesis. We performed a prospective, randomized, non-inferiority trial comparing the Kineflex Disc with the Food and Drug Administration (FDA)-approved Charité device (DePuy Spine, Raynham, Massachus...
STUDY DESIGN Systematic review. STUDY RATIONALE Some have noted several safety issues associated with the use of bone morphogenetic proteins (BMPs), including cancer risk, stating both BMP and their receptors had been isolated from human tumors. In addition, data presented to the US Food and Drug Administration (FDA) on the product AMPLIFY™ (rhBMP-2, 40 mg) revealed a higher number of cance...
STUDY DESIGN Systematic review. CLINICAL QUESTION Does single-level unconstrained, semiconstrained, or fully constrained cervical artificial disc replacement (C-ADR) improve health outcomes compared with single-level anterior cervical discectomy and fusion (ACDF) in the long-term? METHODS A systematic review was undertaken for articles published up to October 2011. Electronic databases a...
OBJECTIVES We undertook the review of all available cases of hypersensitivity reactions after placement of a drug-eluting stent (DES) and classified potential causes. BACKGROUND Six months after the approval of the first DES, the Food and Drug Administration (FDA) reported 50 hypersensitivity reactions after stent placement but later concluded these were due to concomitantly prescribed medica...
PURPOSE On March 25, 2005, bortezomib (Velcade for Injection; Millennium Pharmaceuticals, Inc., Cambridge, MA, and Johnson & Johnson Pharmaceutical Research & Development, L.L.C.) received regular approval from the U.S. Food and Drug Administration (U.S. FDA) for the treatment of multiple myeloma (MM) progressing after at least one prior therapy. This approval was based on bortezomib's efficacy...
نمودار تعداد نتایج جستجو در هر سال
با کلیک روی نمودار نتایج را به سال انتشار فیلتر کنید