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Public Assessment Report Decentralised Procedure Adrenaline 1
Public Assessment Report Decentralised Procedure Adrenaline 1

... the safety profile of adrenaline are considered well established. However, there are limited data in various areas and gaps in the evidence so its use under certain conditions is based mainly on empirical data and expert consensus. The initially submitted clinical overview included a large number of ...
4 4 8 8 9 0 5 MEDICATION GUIDE FLUOXETINE (floo-OX-e
4 4 8 8 9 0 5 MEDICATION GUIDE FLUOXETINE (floo-OX-e

... Adult — Initiate fluoxetine 20 mg/day, orally in the morning. Consider a dose increase after several weeks if insufficient clinical improvement is observed. The full therapeutic effect may be delayed until 5 weeks of treatment or longer. Administer doses above 20 mg/day once daily in the morning or ...
Report of the National Lipid Association`s Statin Safety Task Force
Report of the National Lipid Association`s Statin Safety Task Force

... Health professionals who seek to reduce the consequences of atherosclerotic vascular disease in their patients should be enjoying the best of times. An explosion of discovery and new knowledge has helped define the pathogenesis of atherosclerosis and provide new insights into its insidious effects. ...
Ophthalmology and Eye Diseases Review of Azithromycin
Ophthalmology and Eye Diseases Review of Azithromycin

... one to ­ninety-six who were diagnosed with bacterial ­conjunctivitis.31 Patients were treated with azithromycin 1.0% in ­DuraSite® or tobramycin 0.3%. Out of the 743 patients, 96% of the patients completed the trial. Azithromycin 1.0% dosed twice daily for 2 days then once daily for 3 days achieved ...
1
1

... INDICATIONS AND USAGE Schizophrenia Oral ZYPREXA is indicated for the treatment of schizophrenia. Efficacy was established in three clinical trials in adult patients with schizophrenia: two 6-week trials and one maintenance trial. In adolescent patients with schizophrenia (ages 13-17), efficacy was ...
ARQULE INC - Nasdaq`s INTEL Solutions
ARQULE INC - Nasdaq`s INTEL Solutions

... is to produce novel medicines with differentiated mechanisms of action that target the specific biological pathways implicated in a wide range of cancers. We employ novel technologies such as our ArQule Kinase Inhibitor Platform ("AKIP™") to design and develop drugs that have the potential to fulfil ...
Statins - Amazon Web Services
Statins - Amazon Web Services

... In the United States, coronary heart disease and cardiovascular disease account for nearly 40% of all deaths each year. Coronary heart disease continues to be the leading cause of mortality and a significant cause of morbidity among North Americans. In 2006, coronary heart disease claimed 607 000 li ...
Drug Class Review HMG-CoA Reductase Inhibitors (Statins) and
Drug Class Review HMG-CoA Reductase Inhibitors (Statins) and

... In the United States, coronary heart disease and cardiovascular disease account for nearly 40% of all deaths each year. Coronary heart disease continues to be the leading cause of mortality and a significant cause of morbidity among North Americans. In 2006, coronary heart disease claimed 607 000 li ...
View Full Prescribing Information
View Full Prescribing Information

... Preparation and Dilution in Bag for Infusion 1. Calculate the milligrams of ANTHIM injection needed by multiplying the recommended mg/kg dose in Table 2 by the patient weight in kilograms. 2. Calculate the required volume in milliliters of ANTHIM injection and number of vials needed for the dose by ...
AusPAR: Rifaximin  - Therapeutic Goods Administration
AusPAR: Rifaximin - Therapeutic Goods Administration

... these are discussed under Clinical Findings Pharmacodynamics below. The risk of horizontal dissemination of rifaximin resistance to other bacteria is low. Spontaneous rifaximin‐resistance has been reported in a number of gut organisms; enterococci, Clostridium difficile, Clostridium perfringens and ...
2014 Annual Report - UPMC - Neurology at the University of
2014 Annual Report - UPMC - Neurology at the University of

... cognitively normal and mild cognitive impairment. He is the site project director for the DominantlyInherited Alzheimer’s Network (DIAN) NIA grant and will be site project director for the first DIAN treatment trial in FY 15. He also began a Grifols multicenter, randomized, controlled study to evalu ...
Author`s personal copy - Northern Speech Services
Author`s personal copy - Northern Speech Services

... through the upper aerodigestive tract and simultaneously protect the upper airway. Although the VFSS does not use direct measures of sensation and muscle strength, the following evidence suggests that trained examiners can make accurate and reliable clinical judgments about the presence of sensory a ...
Clinical Studies
Clinical Studies

... levels in southern Africa, and is growing rapidly in the two most populous Asian nations, India and China.1 Changes in sexual behavior (e.g., delay in onset of sexual activity in youth, reduction in the number of partners – including mutual monogamy, and increased condom use) have helped decrease HI ...
EFPIA-EVM-EBE response to EC public
EFPIA-EVM-EBE response to EC public

... discussions now more often occur simultaneously with adult planning, and a systematic evaluation of each new compound to identify paediatric needs and potential value for children, has been embedded into the research and development (R&D) process. Many companies have established dedicated internal a ...
Fexofast Presentation
Fexofast Presentation

... when terfenadine was given at oral doses of up to 300 mg/kg/day throughout organogenesis, which corresponds to levels of systemic fexofenadine exposure fourfold and 32-fold higher, respectively, than those anticipated in clinical use. Decreased pup weight and survival occurred in rats when terfenadi ...
US Product Labeling @std Template for PLR
US Product Labeling @std Template for PLR

... Patients With HIV-1 and Hepatitis B Virus Co-infection Posttreatment Exacerbations of Hepatitis: In clinical trials in non-HIV-1-infected patients treated with lamivudine for chronic HBV, clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of lamivudine ...
Report from the Gastroenterology Clinical Committee
Report from the Gastroenterology Clinical Committee

... The Committee reviewed the data on these items and the relevant clinical guidelines and recommends that these services should reflect the current evidence for the use of colonoscopy, including appropriate intervals between colonoscopies used in surveillance of patients who are at increased risk of d ...
Daptomycin for Injection for Intravenous Use Daptomycin for
Daptomycin for Injection for Intravenous Use Daptomycin for

... in order to isolate and identify the causative pathogens and to determine their susceptibility to daptomycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of daptomycin for injection and other antibacterial drugs, daptomycin for injection should be used only to ...
Final Assessment Report - Word 203 KB
Final Assessment Report - Word 203 KB

... Table 7 Method used to identify the type of analysis .................................................. 18 Table 8 Medline search strategy .................................................................................. 19 Table 9 Embase search strategy ............................................ ...
Report on the Deliberation Results April 27, 2012 Evaluation and
Report on the Deliberation Results April 27, 2012 Evaluation and

... 2 diabetes mellitus has been demonstrated and its safety is acceptable in view of its observed benefits. Safety information on hypoglycemia, gastrointestinal disorder, pancreatitis, hepatic impairment, etc., as well as the safety and efficacy in patients with renal impairment, patients with hepatic ...
NORTHERN ARIZONA UNIVERSITY
NORTHERN ARIZONA UNIVERSITY

...  It is the student’s responsibility to review this form, list two goals, sign and return to instructor. 6. Completed Clinical Evaluations (See Appendix E)  It is the student’s responsibility to ensure that the clinical evaluation form is completed by the clinical faculty and that a signed copy of ...
Cardiovascular Studies Therapeutic Area User Guide v1
Cardiovascular Studies Therapeutic Area User Guide v1

... • Endpoint data is clinical data, and should be standardized at the source wherever possible • Coordinate various cardiology standards efforts to collaboratively produce a single set of work products Standardized definitions of cardiovascular clinical endpoints are needed to objectively and consiste ...
HIGHLIGHTS OF PRESCRIBING INFORMATION These
HIGHLIGHTS OF PRESCRIBING INFORMATION These

... INDICATIONS AND USAGE Schizophrenia Oral ZYPREXA is indicated for the treatment of schizophrenia. Efficacy was established in three clinical trials in adult patients with schizophrenia: two 6-week trials and one maintenance trial. In adolescent patients with schizophrenia (ages 13-17), efficacy was ...
Tenofovir disoproxil fumarate / Emtricitabine
Tenofovir disoproxil fumarate / Emtricitabine

... inhibitors, integrase strand transfer inhibitors, and with nucleoside and non-nucleoside analogue inhibitors of HIV-1 reverse transcriptase. Tenofovir disoproxil fumarate: The in vitro antiviral activity of tenofovir against laboratory and clinical isolates of HIV-1 was assessed in lymphoblastoid ce ...
Zyprexa - Eli Lilly and Company
Zyprexa - Eli Lilly and Company

... INDICATIONS AND USAGE Schizophrenia Oral ZYPREXA is indicated for the treatment of schizophrenia. Efficacy was established in three clinical trials in adult patients with schizophrenia: two 6-week trials and one maintenance trial. In adolescent patients with schizophrenia (ages 13-17), efficacy was ...
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Clinical trial

Clinical trials are experiments done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial - their approval does not mean that the therapy is 'safe' or effective, only that the trial may be conducted.Depending on product type and development stage, investigators initially enroll volunteers and/or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary in size and cost, and they can involve a single research center or multiple centers, in one country or in multiple countries. Clinical study design aims to ensure the scientific validity and reproducibility of the results.Trials can be quite costly, depending on a number of factors. The sponsor may be a governmental organization or a pharmaceutical, biotechnology or medical device company. Certain functions necessary to the trial, such as monitoring and lab work, may be managed by an outsourced partner, such as a contract research organization or a central laboratory.Only 10% of all drugs started in human clinical trials become an approved drug.
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