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November 2014 PBAC Meeting
November 2014 PBAC Meeting

... The PBAC noted in November 2013 that the primary outcome of progression free survival (PFS) in the INTORSECT trial was not statistically significant for sorafenib compared to temsirolimus, however the secondary outcome of overall survival (OS) was statistically significant with a p-value of 0.014. T ...
A Practical Guide for Clinicians Who Treat Patients with Amiodarone
A Practical Guide for Clinicians Who Treat Patients with Amiodarone

... trials, it has not been shown to convert AF to sinus rhythm more effectively, compared to placebo.32 IV amiodarone can help to maintain sinus rhythm after electrical or spontaneous cardioversion and, even then, in many instances, only after 24 – 48 hours. IV loading increases myocardial tissue level ...
1 ENDOCET (Oxycodone and Acetaminophen Tablets, USP) CII Rx
1 ENDOCET (Oxycodone and Acetaminophen Tablets, USP) CII Rx

... milligrams per day, and often involve more than one acetaminophen containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products. The risk of a ...
Sample CMS-1450 (UB-04) Claim Form CMS-1450 (UB-04) Claim Form completion for VELCADE for
Sample CMS-1450 (UB-04) Claim Form CMS-1450 (UB-04) Claim Form completion for VELCADE for

... administered intravenously, the most commonly reported ARs were nausea (49%), diarrhea NOS (46%), fatigue (41%), peripheral neuropathy NEC (38%), and thrombocytopenia (32%). A total of 26% of patients experienced serious ARs. The most commonly reported serious ARs included diarrhea, vomiting, and py ...
Ophthalmic adverse drug reactions to systemic drugs
Ophthalmic adverse drug reactions to systemic drugs

... ADRs can occur after the correct prescription of each drug. A systematic review would be useful not only to identify drugs in which ophthalmic ADRs are frequent or serious, but also to increase knowledge of physicians (prescribing physicians and ophthalmologists), enabling a greater detection of oph ...
Lavela WS 1265 | Information Sheet
Lavela WS 1265 | Information Sheet

... Rating Scale (HAM-A total score) was used as the primary objective measurement to monitor changes in the level of tension and relaxation beginning at baseline through week 6 of the trial. Additional data was collected using the Self-Rating Anxiety Scale, Penn State Worry Questionnaire, SF 36 Health ...
Evaluation of Multiple Dosing Regimens in Phase 2 Studies of
Evaluation of Multiple Dosing Regimens in Phase 2 Studies of

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$doc.title

... A second study compared primarily 1200 mg/day divided TID Neurontin (N=101) with placebo (N=98). Additional smaller Neurontin dosage groups (600 mg/day, N=53; 1800 mg/day, N=54) were also studied for information regarding dose response. Responder rate was higher in the Neurontin 1200 mg/day group (1 ...
Volume 4, Supplement 1
Volume 4, Supplement 1

... chemistry and biological advances in the fundamental and clinical study of antiviral diseases and their treatment. Areas covered include HIV, hepatitis B, hepatitis C and emerging viruses, co-infections, vaccines, animal models, pharmacology, microbicides, alternative therapies, viral dynamics and r ...
Octroflex solution for injection ENG SmPC
Octroflex solution for injection ENG SmPC

... There is a limited amount of data (less than 300 pregnancy outcomes) from the use of octreotide in pregnant women, and in approximately one third of the cases the pregnancy outcomes are unknown. The majority of reports were received after post-marketing use of octreotide and more than 50% of exposed ...
multiple-choice tests in pharmacology
multiple-choice tests in pharmacology

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Selegiline transdermal system in major depressive disorder
Selegiline transdermal system in major depressive disorder

... The efficacy of STS as an acute treatment for MDD was established in two, randomized, double-blind, placebo-controlled studies of 6 and 8 weeks duration in adult outpatients (aged 18– 70 years) with moderate-to-severe depression and meeting Diagnostic and Statistical Manual of Mental Disorders (DSM- ...
Attention Deficit Hyperactivity Disorder (ADHD) Evaluating Prescription Drugs Used to Treat:
Attention Deficit Hyperactivity Disorder (ADHD) Evaluating Prescription Drugs Used to Treat:

... as hyperactivity and impulsivity, under control, which may improve a person’s daily functioning. However, there is no good evidence showing that these benefits last for longer than two years, so you may want to periodically discuss with your physician whether you should continue to take the medicine ...
Provisional PDF - Nanoscale Research Letters
Provisional PDF - Nanoscale Research Letters

... (Guangzhou, China) and performed in accordance with the National Institute of Health and Nutrition Guidelines for the Care and Use of Laboratory Animals. Six beagle dogs (1.2 to 2.0 years of age) weighing 12 to 14 kg were acclimatized in an environmentally controlled breeding room for 1 week, before ...
Medicare National and Local Coverage Determination Policy- CT, MA, ME,...
Medicare National and Local Coverage Determination Policy- CT, MA, ME,...

... BNP measurements must be analyzed in conjunction with standard diagnostic tests, medical history and clinical findings. The efficacy of BNP measurement as a stand-alone test has not yet been established. Clinicians should be aware that certain conditions such as ischemia, infarction and renal insuff ...
Prepared By - Beckman Coulter
Prepared By - Beckman Coulter

... Interpretation of Results The factors that can influence the relationship between the phenobarbital serum or plasma concentrations and clinical response include the type and severity of seizures, age, general state of health, and use of other drugs. The concentration of phenobarbital in serum or pla ...
Studies of Retroviral Reverse Transcriptase and
Studies of Retroviral Reverse Transcriptase and

... clinical trials complete Phases I and II successfully and pass to Phase III. In Phase III the candidate drug is administered to a larger group (hundreds to thousands) of patients with the goal to demonstrate its safety and prove its effectiveness over existing standard therapies. After successful co ...
Updated European Heart Rhythm Association
Updated European Heart Rhythm Association

... in particular, they offer less guidance on how to deal with NOACs in specific clinical situations. Moreover, there are still underexplored aspects of NOAC use that is relevant when these drugs are used by cardiologists, neurologists, geriatricians, and general practitioners. Each of the NOACs availa ...
BRAF Gene Mutation Testing To Select Melanoma Patients for
BRAF Gene Mutation Testing To Select Melanoma Patients for

... POLICY GUIDELINES It is critical that the list of information below is submitted for review to determine if the policy criteria are met. If any of these items are not submitted, it could impact our review and decision outcome. 1. Name of the genetic test(s) or panel test 2. Name of the performing la ...
Psychostimulants in the treatment of children diagnosed with ADHD
Psychostimulants in the treatment of children diagnosed with ADHD

... Europe and Australia. In 1995, the International Narcotics Control Board (INCB) showed concern that “10 to 12 percent of all boys between the ages of 6 and 14 in the United States have been diagnosed as having ADD and are being treated with methylphenidate” (p. 2). Recently, the US Drug Enforcement ...
Updated European Heart Rhythm Association Practical
Updated European Heart Rhythm Association Practical

... in particular, they offer less guidance on how to deal with NOACs in specific clinical situations. Moreover, there are still underexplored aspects of NOAC use that is relevant when these drugs are used by cardiologists, neurologists, geriatricians, and general practitioners. Each of the NOACs availa ...
Updated European Heart Rhythm Association - prof
Updated European Heart Rhythm Association - prof

... in particular, they offer less guidance on how to deal with NOACs in specific clinical situations. Moreover, there are still underexplored aspects of NOAC use that is relevant when these drugs are used by cardiologists, neurologists, geriatricians, and general practitioners. Each of the NOACs availa ...
Updated European Heart Rhythm Association Practical Guide on the
Updated European Heart Rhythm Association Practical Guide on the

... in particular, they offer less guidance on how to deal with NOACs in specific clinical situations. Moreover, there are still underexplored aspects of NOAC use that is relevant when these drugs are used by cardiologists, neurologists, geriatricians, and general practitioners. Each of the NOACs availa ...
development and validation of rp-hplc method for simultaneous
development and validation of rp-hplc method for simultaneous

... Modern college of pharmacy, Pune, India for providing ...
Estimating changes in overall survival using progression
Estimating changes in overall survival using progression

... In a clinical trial where a new treatment for cancer is being compared with a standard or alternative treatment, it will generally be the case that reliable data for disease-free or progression-free survival will become available far sooner than reliable data for overall survival. Therefore, despite ...
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Bad Pharma



Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients is a book by British physician and academic Ben Goldacre about the pharmaceutical industry, its relationship with the medical profession, and the extent to which it controls academic research into its own products. The book was published in September 2012 in the UK by the Fourth Estate imprint of HarperCollins, and in February 2013 in the United States by Faber and Faber.Goldacre argues in the book that ""the whole edifice of medicine is broken"" because the evidence on which it is based is systematically distorted by the pharmaceutical industry. He writes that the industry finances most of the clinical trials into its own products and much of doctors' continuing education, that clinical trials are often conducted on small groups of unrepresentative subjects and negative data is routinely withheld, and that apparently independent academic papers may be planned and even ghostwritten by pharmaceutical companies or their contractors, without disclosure. Goldacre calls the situation a ""murderous disaster,"" and makes suggestions for action by patients' groups, physicians, academics and the industry itself.Responding to the book's publication, the Association of the British Pharmaceutical Industry issued a statement arguing that the examples the book offers are historical, that the concerns have been addressed, that the industry is among the most regulated in the world, and that it discloses all data in accordance with international standards.In January 2013 Goldacre joined the Cochrane Collaboration, British Medical Journal and others in setting up AllTrials, a campaign calling for the results of all past and current clinical trials to be reported. The British House of Commons Public Accounts Committee expressed concern in January 2014 that drug companies were still only publishing around 50 percent of clinical-trial results.
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