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Prescribing Information for SEROQUEL XR - PI
Prescribing Information for SEROQUEL XR - PI

... • 50 mg extended-release tablets are peach, film coated, capsule-shaped, biconvex, intagliated tablet with “XR 50” on one side and plain on the other side • 150 mg extended-release tablets are white, film-coated, capsule-shaped, biconvex, intagliated tablet with “XR 150” on one side and plain on the ...
`Cut down to quit` with nicotine replacement therapies in
`Cut down to quit` with nicotine replacement therapies in

... Secondly, the HTA Programme provides grants for clinical trials for researchers who identify research questions. These are assessed for importance to patients and the NHS, and scientific rigour. Thirdly, through its Technology Assessment Report (TAR) call-off contract, the HTA Programme commissions ...
Is This Child Dehydrated? THE RATIONAL CLINICAL EXAMINATION
Is This Child Dehydrated? THE RATIONAL CLINICAL EXAMINATION

... (1 month to 5 years). Data Extraction Two of the 3 authors independently reviewed and abstracted data for estimating the likelihood ratios (LRs) of diagnostic tests. We eliminated 13 of the 26 studies because of the lack of an accepted diagnostic standard or other limitation in study design. The oth ...
Type 2 diabetes: newer agents for blood glucose control in type 2
Type 2 diabetes: newer agents for blood glucose control in type 2

... • The recommendations cover those drugs named in the scope and their licensed indications at the time (changes after September 2008 were not considered). They exclude liraglutide, which did not receive marketing authorisation for use in type 2 diabetes during the development of the guideline (Decemb ...
ST 520: Statistical Principles of Clinical Trials and Epidemiology
ST 520: Statistical Principles of Clinical Trials and Epidemiology

... The cases were as similar as I could have them... they lay together in one place... and had one common diet to them all... To two of them was given a quart of cider a day, to two an elixir of vitriol, to two vinegar, to two oranges and lemons, to two a course of sea water, and to the remaining two t ...
EUnetHTA WP5 Joint Action 2 (2012
EUnetHTA WP5 Joint Action 2 (2012

... the EUnetHTA guidelines for handling conflict of interest. Professor Dennis acted in an unpaid and informal advisory capacity for a DPDO responsible for the health technology under assessment (Medtronic). In addition, Professor Dennis declared to have carried out clinical studies in relation to the ...
DOC - Investor Relations
DOC - Investor Relations

... SL-401 is being advanced through a Phase 2 pivotal trial in patients with blastic plasmacytoid dendritic cell neoplasm, or BPDCN. Thirty-two BPDCN patients have been enrolled in Stages 1 and 2 of the trial. In August 2016, SL-401 was granted Breakthrough Therapy Designation, or BTD, from the U.S. Fo ...
Rare Diseases and Orphan Products: Accelerating Research and Development  PREPUBLICATION COPY
Rare Diseases and Orphan Products: Accelerating Research and Development PREPUBLICATION COPY

... millions of individuals in the United States and are responsible for untold losses in terms of physical health, behavioral health, and socioeconomic condition. Physicians, nurses, and others who care for this group of patients recognize the huge burden on patients, families, communities, the health ...
The PROMUS® Everolimus Eluting Coronary Stent System
The PROMUS® Everolimus Eluting Coronary Stent System

... Stent thrombosis is a low-frequency event that is frequently associated with myocardial infarction (MI) or death. Data from the SPIRIT family of clinical trials have been prospectively evaluated and adjudicated using both the protocol definition of stent thrombosis and the definition developed by th ...
DOC - Investor Relations
DOC - Investor Relations

... This annual report on Form 10-K (“Form 10-K”) includes statements that are, or may be deemed, “forward-looking statements.” In some cases, these forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes,” “estimates,” “anticipates,” “expect ...
1
1

... Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Therefore, treatments for erectile dysfunction, including CIALIS, should not be used in men for whom sexual activity is inadvisable as a result of their un ...
AERIUS® AERIUS KIDS®
AERIUS® AERIUS KIDS®

... In a single dose crossover study of desloratadine, the tablet and syrup formulations were found to be bioequivalent. In separate single dose studies, at the recommended doses, pediatric patients had comparable AUC and Cmax values of desloratadine to those in adults who received a 5 mg dose of deslo ...
Boston Scientific Inc. PROMUSâ„¢ Everolimus Eluting Coronary
Boston Scientific Inc. PROMUSâ„¢ Everolimus Eluting Coronary

... Stent thrombosis is a low-frequency event that is frequently associated with myocardial infarction (MI) or death. Data from the SPIRIT family of clinical trials have been prospectively evaluated and adjudicated using both the protocol definition of stent thrombosis and the definition developed by th ...
Product Monograph - Ask Novartis Pharma
Product Monograph - Ask Novartis Pharma

... studies, and so, no data exist on the use of TOBI PODHALER in these patients. The use of TOBI PODHALER in such patients should be undertaken only if the benefits of treatment are considered to outweigh the risks of inducing further hemorrhage. Sensitivity/Resistance Decrease in susceptibility to tob ...
Effect of St John`s Wort on Drug Metabolism by Induction of
Effect of St John`s Wort on Drug Metabolism by Induction of

... Main Outcome Measures Changes in plasma pharmacokinetics of alprazolam as a probe for CYP 3A4 activity and the ratio of dextromethorphan to its metabolite, dextrorphan, in urine as a probe for CYP 2D6 activity. Results A 2-fold decrease in the area under the curve for alprazolam plasma concentration ...
Developing Cures, Creating Jobs
Developing Cures, Creating Jobs

... clinicians and drug reviewers can develop accurate assessments of the efficacy and safety of medicines when used by patients.The Food and Drug Administration (FDA) is a vigilant regulatory agency and its pharmaceutical review officers are effective in detecting flawed information. Questionable or co ...
Efficacy of clinical hypnosis: A summary of its empirical evidence
Efficacy of clinical hypnosis: A summary of its empirical evidence

... suffering from post-traumatic stress are highly hypnotizable, therefore, they may benefit from hypnosis more than most other patient populations (Bryant, Guthrie, & Moulds, 2001; Spiegel, Hunt, & Dondershine, 1988; Stutman & Bliss, 1985). Consequently, more research is required in this area so that ...
PL 18909/0286
PL 18909/0286

... stomach Risedronate 35 mg tablet is to be taken while in an upright position with a glass of plain water (>120 ml). Patients should not lie down for 30 minutes after taking the tablet (see section 4.4). Supplemental calcium and vitamin D should be considered if the dietary intake is inadequate. Elde ...
Gingival Problems
Gingival Problems

... treatment and therapeutic outcomes for plaqueinduced gingivitis. These may include diabetes, smoking, and certain periodontal bacteria, aging, gender, genetic predisposition, systemic diseases and conditions (immunosuppression), stress, nutrition, pregnancy, substance abuse, HIV infection, and medic ...
Ranibizumab and pegaptanib for the treatment of age
Ranibizumab and pegaptanib for the treatment of age

... Secondly, the HTA Programme provides grants for clinical trials for researchers who identify research questions. These are assessed for importance to patients and the NHS, and scientific rigour. Thirdly, through its Technology Assessment Report (TAR) call-off contract, the HTA Programme commissions ...
2012 Update: World Allergy Organization Guidelines for the assessment and management
2012 Update: World Allergy Organization Guidelines for the assessment and management

... (subsequently referred to as the Guidelines) were published on 3 March 2011 [1 ] in response to the need for global guidelines on anaphylaxis diagnosis and treatment. Unique aspects of the Guidelines are summarized below. The Guidelines were developed without corporate funding in response to absence ...
Product Information for Aripiprazole Monohydrate
Product Information for Aripiprazole Monohydrate

... of patients with psychosis associated with dementia have not been established. Abilify Maintena is not indicated for the treatment of patients with dementia-related psychosis. General During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks. ...
Report on the Deliberation Results December 3, 2012 Evaluation
Report on the Deliberation Results December 3, 2012 Evaluation

... may be approved and that this result should be reported to the Pharmaceutical Affairs Department of the Pharmaceutical Affairs and Food Sanitation Council. The product is not classified as a biological product or a specified biological product and its reexamination period should be until September 2 ...
Glucosamine sulfate.fm
Glucosamine sulfate.fm

... synovial fluid [11]. However, it also exerts specific pharmacological effects on osteoarthritic cartilage and chondrocytes. Glucosamine base must be salified for pharmaceutical use, and glucosamine sulfate is the salt that was originally developed as a prescription drug and used in the vast majority ...
Clinical Pharmacology and Therapeutics Curriculum August 2010
Clinical Pharmacology and Therapeutics Curriculum August 2010

... domains of Good Medical Practice to the curriculum has also provided the opportunity to define skills and behaviours which trainees require to communicate better with patients, carers and their families and how these will be assessed. The new curriculum in CPT is designed to attract sufficient high- ...
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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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