Clinical Information For Drugs Covered Under the - e
... Diagnosis of androgen deficiency syndrome in a male patient o TWO morning testosterone levels in the past year below the testing laboratory’s lower limit of normal range (Free testosterone levels may be required.) o Evidence of at least TWO specific signs and/or symptoms of testosterone deficiency ...
... Diagnosis of androgen deficiency syndrome in a male patient o TWO morning testosterone levels in the past year below the testing laboratory’s lower limit of normal range (Free testosterone levels may be required.) o Evidence of at least TWO specific signs and/or symptoms of testosterone deficiency ...
The Plan for Promotion of Medical Research and Development
... to examine diseases in humans and will lay the foundations for the development of drugs and medical devices for use in treatment and diagnosis. However, to enable new drugs and medical devices to be used in clinical settings once their safety has been confirmed, clinical research 1 and trials must b ...
... to examine diseases in humans and will lay the foundations for the development of drugs and medical devices for use in treatment and diagnosis. However, to enable new drugs and medical devices to be used in clinical settings once their safety has been confirmed, clinical research 1 and trials must b ...
Safety of allopurinol compared with other urate
... There were a total of seven randomized, double-blind, placebo-controlled trials and four systematic reviews in this review including data on allopurinol safety. We did not identify any cohort in our literature search. Appendix 3 summarizes information about 4 reviews which include articles already c ...
... There were a total of seven randomized, double-blind, placebo-controlled trials and four systematic reviews in this review including data on allopurinol safety. We did not identify any cohort in our literature search. Appendix 3 summarizes information about 4 reviews which include articles already c ...
AusPAR: Tafluprost/Timolol - Therapeutic Goods Administration
... The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary. ...
... The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary. ...
CUBICIN ® Product Monograph - Sunovion Pharmaceuticals
... Nursing Women: Data from a single case indicated that daptomycin is present in human milk. Daptomycin is poorly bioavailable orally. Due to limited data, breastfeeding should be discontinued during treatment with CUBICIN®. Pediatrics (<18 years of age): The safety and efficacy of CUBICIN® in patient ...
... Nursing Women: Data from a single case indicated that daptomycin is present in human milk. Daptomycin is poorly bioavailable orally. Due to limited data, breastfeeding should be discontinued during treatment with CUBICIN®. Pediatrics (<18 years of age): The safety and efficacy of CUBICIN® in patient ...
Best Drugs for Avoiding Paradoxical Bronchospasm
... Background: Asthma could be diagnosed by its characteristic presentation. Spirometry can help the diagnosis by revealing post-bronchodilator response. Classically, salbutamol (albuterol) is used for evaluating post-bronchodilator response. This drug causes paradoxical bronchospasm in less than 10% o ...
... Background: Asthma could be diagnosed by its characteristic presentation. Spirometry can help the diagnosis by revealing post-bronchodilator response. Classically, salbutamol (albuterol) is used for evaluating post-bronchodilator response. This drug causes paradoxical bronchospasm in less than 10% o ...
Glucosamine Chondroitin MSM + Hyaluronic Acid
... volunteers, it was determined that long-term daily supplementation with glucosamine sulfate (at 1,500 mg for at least 3 years) or chondroitin sulfate (at 800 mg for at least 2 years) supported maintenance of knee joint structure over the years, compared to placebo.3 In a recent report, a British phy ...
... volunteers, it was determined that long-term daily supplementation with glucosamine sulfate (at 1,500 mg for at least 3 years) or chondroitin sulfate (at 800 mg for at least 2 years) supported maintenance of knee joint structure over the years, compared to placebo.3 In a recent report, a British phy ...
Personalized Oncology Through High
... and heterogeneity is the rule. This is clearly evident in the clinical management of cancer where a “one size fits all” approach is not effective. Thus, the personalization of therapy for cancer will require molecular characterization of unique and shared genetic alterations. Today, the promise of p ...
... and heterogeneity is the rule. This is clearly evident in the clinical management of cancer where a “one size fits all” approach is not effective. Thus, the personalization of therapy for cancer will require molecular characterization of unique and shared genetic alterations. Today, the promise of p ...
Cancer Association of South Africa (CANSA) Fact Sheet
... important questions and help move research forward. Patients can enter clinical trials before, during, or after starting their cancer treatment. Some clinical trials only include patients who have not yet received treatment. Other trials test treatments for patients whose cancer has not gotten bett ...
... important questions and help move research forward. Patients can enter clinical trials before, during, or after starting their cancer treatment. Some clinical trials only include patients who have not yet received treatment. Other trials test treatments for patients whose cancer has not gotten bett ...
Genvoya - Gilead
... inhibitor, and emtricitabine and tenofovir alafenamide (TAF), both HIV1 nucleoside analog reverse transcriptase inhibitors (NRTIs), and is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older weighing at least 35 kg who have ...
... inhibitor, and emtricitabine and tenofovir alafenamide (TAF), both HIV1 nucleoside analog reverse transcriptase inhibitors (NRTIs), and is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older weighing at least 35 kg who have ...
Diapositive 1 - Moodle Lille 2
... - 2006: Prediction sales for 2010 7$ billion - 2009: Prediction sales for 2009 1,2$ billion ...
... - 2006: Prediction sales for 2010 7$ billion - 2009: Prediction sales for 2009 1,2$ billion ...
... National Health and Medical Research Council (NHMRC) publication A Guide to the Development, Implementation and Evaluation of Clinical Practice Guidelines (NHMRC 1999). This recommends that guidelines should be developed by a multidisciplinary guideline development committee, the initial task of whi ...
Medical Devices - Icahn School of Medicine
... Special Cases for use of an unapproved device, or an approved device for an unapproved indication An unapproved medical device may normally only be used on human subjects through an approved clinical study in which the subjects meet certain criteria and the device is only used in accordance with the ...
... Special Cases for use of an unapproved device, or an approved device for an unapproved indication An unapproved medical device may normally only be used on human subjects through an approved clinical study in which the subjects meet certain criteria and the device is only used in accordance with the ...
Edinburgh Research Explorer
... arm, subjects received active drug in a twice-daily loading dose on days 1 and 2 and once daily on days 3–5 and vehicle drops were administered at other times. On day 6, clinical resolution rates of 1% azithromycin in DuraSite® were found to be equivalent to 0.3% tobramycin (79.9% vs 78.3%; P = 0.7 ...
... arm, subjects received active drug in a twice-daily loading dose on days 1 and 2 and once daily on days 3–5 and vehicle drops were administered at other times. On day 6, clinical resolution rates of 1% azithromycin in DuraSite® were found to be equivalent to 0.3% tobramycin (79.9% vs 78.3%; P = 0.7 ...
FOxTROT Protocol - University of Birmingham
... Postoperative chemotherapy improves survival for patients with stage III (node-positive) colorectal cancer. There is now also good evidence – from the QUASAR1 study and meta-analysis - that survival is improved in stage II (node-negative) disease. However, for many patients the current treatment str ...
... Postoperative chemotherapy improves survival for patients with stage III (node-positive) colorectal cancer. There is now also good evidence – from the QUASAR1 study and meta-analysis - that survival is improved in stage II (node-negative) disease. However, for many patients the current treatment str ...
Product Monograph - Novo Nordisk Canada
... the assistance of another person for treatment occurred in 8 VICTOZA® treated patients. In another clinical trial comparing VICTOZA®+metformin to sitagliptin+metformin (Trial NN2211-1860), 1 additional major episode of hypoglycemia was reported in a VICTOZA® treated patient. In total, 9 patients tre ...
... the assistance of another person for treatment occurred in 8 VICTOZA® treated patients. In another clinical trial comparing VICTOZA®+metformin to sitagliptin+metformin (Trial NN2211-1860), 1 additional major episode of hypoglycemia was reported in a VICTOZA® treated patient. In total, 9 patients tre ...
Pro
... tablet Grazax (Phleum pratense 75,000 SQ-T/2,800 BAU). They conduced a randomized, double-blind, placebo-controlled, phase III trial including adults with a history of moderate-to-severe grass pollen induced rhinoconjunctivitis that was inadequately controlled by symptomatic medication use. The resu ...
... tablet Grazax (Phleum pratense 75,000 SQ-T/2,800 BAU). They conduced a randomized, double-blind, placebo-controlled, phase III trial including adults with a history of moderate-to-severe grass pollen induced rhinoconjunctivitis that was inadequately controlled by symptomatic medication use. The resu ...
Valsartan + Captopril - Duke Clinical Research Institute
... Dr. Pfeffer is named as a coinventor on a patent awarded to the Brigham and Women’s Hospital regarding the use of inhibitors of the renin-angiotensin system in selected survivors of myocardial infarction; there is a licensing agreement between Novartis Pharmaceuticals and the Brigham and Women’s Hos ...
... Dr. Pfeffer is named as a coinventor on a patent awarded to the Brigham and Women’s Hospital regarding the use of inhibitors of the renin-angiotensin system in selected survivors of myocardial infarction; there is a licensing agreement between Novartis Pharmaceuticals and the Brigham and Women’s Hos ...
Clinical Use of Dietary Supplements and Nutraceuticals
... ventional,” “alternative,” or, when used in combination with FDA-approved therapies, “complementary” or “integrative.” For the purposes of these guidelines and the sake of clarity, the term “unproven” will refer to any intervention with insufficient scientific substantiation to support a specific cl ...
... ventional,” “alternative,” or, when used in combination with FDA-approved therapies, “complementary” or “integrative.” For the purposes of these guidelines and the sake of clarity, the term “unproven” will refer to any intervention with insufficient scientific substantiation to support a specific cl ...
AusPAR: Trastuzumab
... The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary. ...
... The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary. ...
Off-label antibiotic use in children in three European countries
... Hospital and Evelina Children’s Hospital in London), one in Italy (Department of Maternal and Pediatric Sciences of the University of Milan), and one in Greece (Aglaia Kyriakou Children’s Hospital, University of Athens). All data on the four sites were collected by the same investigator (AP) during ...
... Hospital and Evelina Children’s Hospital in London), one in Italy (Department of Maternal and Pediatric Sciences of the University of Milan), and one in Greece (Aglaia Kyriakou Children’s Hospital, University of Athens). All data on the four sites were collected by the same investigator (AP) during ...
Emtriva - Gilead Sciences, Inc.
... Clinical Trials in Adult Subjects More than 2,000 adult subjects with HIV-1 infection have been treated with EMTRIVA alone or in combination with other antiretroviral agents for periods of 10 days to 200 weeks in clinical trials. Because clinical trials are conducted under widely varying conditions, ...
... Clinical Trials in Adult Subjects More than 2,000 adult subjects with HIV-1 infection have been treated with EMTRIVA alone or in combination with other antiretroviral agents for periods of 10 days to 200 weeks in clinical trials. Because clinical trials are conducted under widely varying conditions, ...
(EDM) Reference Model - Drug Information Association
... practice, nothing will move,” said Scribner. “We needed a structure for the vendors to see.” Hence, the group presented the model to 12 vendors from various industries in the summer and fall of 2008. The DIA EDM Reference Model version 1.0 was released in the fall of 2008 and demonstrated by selecte ...
... practice, nothing will move,” said Scribner. “We needed a structure for the vendors to see.” Hence, the group presented the model to 12 vendors from various industries in the summer and fall of 2008. The DIA EDM Reference Model version 1.0 was released in the fall of 2008 and demonstrated by selecte ...
Topical treatment for cutaneous leishmaniasis Tracy Garnier
... like MCL and DCL. Generally the New World species tend to cause more severe and longer infections than the Old World species [15,16]. Therapeutic response is dependent on efficiency of host immune response and genetic makeup. Unfortunately, many published reports on treatment are based upon small, u ...
... like MCL and DCL. Generally the New World species tend to cause more severe and longer infections than the Old World species [15,16]. Therapeutic response is dependent on efficiency of host immune response and genetic makeup. Unfortunately, many published reports on treatment are based upon small, u ...
Comparison of the efficacies of normal saline versus hypertonic
... of cyanosis, and auscultatory findings. Based on this scoring system, those patients who had mild and moderate degree of bronchiolitis were included into our study; those with severe attacks were excluded. Length of hospital stay, determined according to standardized discharge criteria, was also rec ...
... of cyanosis, and auscultatory findings. Based on this scoring system, those patients who had mild and moderate degree of bronchiolitis were included into our study; those with severe attacks were excluded. Length of hospital stay, determined according to standardized discharge criteria, was also rec ...