Extract from the Clinical Evaluation Report for Diemthyl Fumarate
... the US National MS Society’s International Advisory Committee on Clinical Trials of New Agents in MS [Polman 2008] and TGA adopted European Union “Guideline on Clinical Investigation of Medicinal Products for the Treatment of Multiple Sclerosis” (CPMP/EWP/561/98 Rev. 1).1 The sponsor also sought gui ...
... the US National MS Society’s International Advisory Committee on Clinical Trials of New Agents in MS [Polman 2008] and TGA adopted European Union “Guideline on Clinical Investigation of Medicinal Products for the Treatment of Multiple Sclerosis” (CPMP/EWP/561/98 Rev. 1).1 The sponsor also sought gui ...
UNITED BRISTOL HEALTHCARE NHS TRUST
... Where BRD is the sponsor of a blinded research study in which the SAE/SUSAR has occurred, the R&D Department will make an unblinded assessment of intensity, causality, expectedness and seriousness using the criteria described in section 6. In making this assessment the R&D Department will consult th ...
... Where BRD is the sponsor of a blinded research study in which the SAE/SUSAR has occurred, the R&D Department will make an unblinded assessment of intensity, causality, expectedness and seriousness using the criteria described in section 6. In making this assessment the R&D Department will consult th ...
ANTIMICROBIAL SUSCEPTIBILITY TESTING
... http://wwwn.cdc.gov/clia/.2 The verification process includes reviewing current literature on the new antimicrobial susceptibility test system, reviewing information from the instrument manufacturer, and performing an evaluation in the clinical laboratory by testing control and clinical isolates. ...
... http://wwwn.cdc.gov/clia/.2 The verification process includes reviewing current literature on the new antimicrobial susceptibility test system, reviewing information from the instrument manufacturer, and performing an evaluation in the clinical laboratory by testing control and clinical isolates. ...
AusPAR: Normal Human Immunoglobulin
... 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. ...
Newer Agents for the Management of Overactive Bladder
... incontinence, urgency, or frequency. It has been in use in Europe for more than 20 years. Unlike other anticholinergics, trospium is water soluble and crosses the blood-brain barrier poorly.9 Although it has been suggested that this feature might minimize centrally mediated events such as drowsiness ...
... incontinence, urgency, or frequency. It has been in use in Europe for more than 20 years. Unlike other anticholinergics, trospium is water soluble and crosses the blood-brain barrier poorly.9 Although it has been suggested that this feature might minimize centrally mediated events such as drowsiness ...
Pfizer at American Society of Clinical Oncology Annual Meeting on
... So one of the Phase II results that was presented here was, I thought, worth sharing, and this was a trial in which patients with previously untreated renal cell cancer, so this is first-line data, but in a second line setting, so it was not compared against another agent, were treated with single-a ...
... So one of the Phase II results that was presented here was, I thought, worth sharing, and this was a trial in which patients with previously untreated renal cell cancer, so this is first-line data, but in a second line setting, so it was not compared against another agent, were treated with single-a ...
Public Health Plan for the Pharmaceutical Treatment of Hepatitis C
... 51% at 1 and 5 years. In addition the annual risk of developing HCC in this patient group was greater than 5% per annum.(23) Another study examined the natural history of patients with HCV cirrhosis.(24) The study examined the outcomes of 1050 patients (60% advanced fibrosis and 40% cirrhosis) over ...
... 51% at 1 and 5 years. In addition the annual risk of developing HCC in this patient group was greater than 5% per annum.(23) Another study examined the natural history of patients with HCV cirrhosis.(24) The study examined the outcomes of 1050 patients (60% advanced fibrosis and 40% cirrhosis) over ...
Safety Factsheet
... The well-being of the participants was monitored during the trial through clinical examinations and laboratory tests. All participants in CAPRISA 004 were monitored clinically every month, so if an adverse event occurred, it was promptly diagnosed and managed. Each participant was tested monthly for ...
... The well-being of the participants was monitored during the trial through clinical examinations and laboratory tests. All participants in CAPRISA 004 were monitored clinically every month, so if an adverse event occurred, it was promptly diagnosed and managed. Each participant was tested monthly for ...
Efficacy and tolerability of the new antiepileptic drugs I - Doctors
... Recent studies7,8 have indicated that patients with newly diagnosed epilepsy can be categorized into those who are treatment responsive or treatment resistant. In fact, approximately two thirds of patients will become seizure free with the first or second drug administered. In recent studies, these ...
... Recent studies7,8 have indicated that patients with newly diagnosed epilepsy can be categorized into those who are treatment responsive or treatment resistant. In fact, approximately two thirds of patients will become seizure free with the first or second drug administered. In recent studies, these ...
A randomised, double blind, placebo-controlled, parallel group Trial
... Since alteplase has a ‘deep tissue’ half life of up to 40 minutes, effective local thrombolysis during the procedure, alteplase is intended to treat and reduce persistent MVO at that time. Methodology: ...
... Since alteplase has a ‘deep tissue’ half life of up to 40 minutes, effective local thrombolysis during the procedure, alteplase is intended to treat and reduce persistent MVO at that time. Methodology: ...
First Oral Dose in Humans
... uations. This definition does not necessarily preclude the use that if there is no reason to “front-load” (e.g., for a highof simple formulations such as CIB for Phase II clinical efficacy solubility or high-permeability drug), the first choice would be studies. However, such situations are less lik ...
... uations. This definition does not necessarily preclude the use that if there is no reason to “front-load” (e.g., for a highof simple formulations such as CIB for Phase II clinical efficacy solubility or high-permeability drug), the first choice would be studies. However, such situations are less lik ...
Endovascular Thermal Ablation Technologies for Treatment
... affect the great (GSV) and small (SSV) saphenous veins in the lower limbs.1,2 Varicose veins are caused by decreased elasticity of the vein wall and poorly functioning valves within the vein, resulting in blood pooling in the veins and vein enlargement.2,3 The symptoms of varicose veins can range in ...
... affect the great (GSV) and small (SSV) saphenous veins in the lower limbs.1,2 Varicose veins are caused by decreased elasticity of the vein wall and poorly functioning valves within the vein, resulting in blood pooling in the veins and vein enlargement.2,3 The symptoms of varicose veins can range in ...
American College of Rheumatology
... Other than aspirin or other antithrombotic therapies to prevent stroke, only symptomatic therapies are available for most neuropsychiatric indications, including anticonvulsants, anti-psychotics, anxiolytics, and immunosuppression to reduce inflammation, all with mixed evidence as to their benefits. ...
... Other than aspirin or other antithrombotic therapies to prevent stroke, only symptomatic therapies are available for most neuropsychiatric indications, including anticonvulsants, anti-psychotics, anxiolytics, and immunosuppression to reduce inflammation, all with mixed evidence as to their benefits. ...
- Ophthalmology
... reports have suggested that repeated intravitreal injections of therapy took great care to adhere to protocols for measuring IOP, antievascular endothelial growth factor drugs can lead to and a consensus as to how IOP should be measured has been persistent elevation of intraocular pressure (IOP). Th ...
... reports have suggested that repeated intravitreal injections of therapy took great care to adhere to protocols for measuring IOP, antievascular endothelial growth factor drugs can lead to and a consensus as to how IOP should be measured has been persistent elevation of intraocular pressure (IOP). Th ...
Cinical Document Indexing Guidance v3.0
... The provision of electronic solutions to support this increased clinical information document sharing relies on effective, efficient and consistent indexing naming, filing and metadata tagging of the same kinds of documents across all NHS boards sharing partners (which may be all boards). In recent ...
... The provision of electronic solutions to support this increased clinical information document sharing relies on effective, efficient and consistent indexing naming, filing and metadata tagging of the same kinds of documents across all NHS boards sharing partners (which may be all boards). In recent ...
Recommendations for the development of rare disease drugs using
... and adapting the development process for these rare diseases is now an important part of assuring that many of the rarest and most difficult-to-treat rare diseases have specific drugs developed. In the United States and European Union, the regulatory approval of any new drug is based on its benefitr ...
... and adapting the development process for these rare diseases is now an important part of assuring that many of the rarest and most difficult-to-treat rare diseases have specific drugs developed. In the United States and European Union, the regulatory approval of any new drug is based on its benefitr ...
Evaluation of the clinical efficacy and safety of “Anti-Dandruff
... dermal inflammation and tissue damage. Currently available treatment options have various limitations, either due to poor clinical efficacy or due to the compliance issues. Also, these drugs are unable to prevent recurrence, which is the commonest problem. This study was planned to evaluate the clin ...
... dermal inflammation and tissue damage. Currently available treatment options have various limitations, either due to poor clinical efficacy or due to the compliance issues. Also, these drugs are unable to prevent recurrence, which is the commonest problem. This study was planned to evaluate the clin ...
PROZAC
... Age--The disposition of single doses of fluoxetine in healthy elderly subjects (greater than 65 years of age) did not differ significantly from that in younger normal subjects. However, given the long half-life and nonlinear disposition of the drug, a single-dose study is not adequate to rule out th ...
... Age--The disposition of single doses of fluoxetine in healthy elderly subjects (greater than 65 years of age) did not differ significantly from that in younger normal subjects. However, given the long half-life and nonlinear disposition of the drug, a single-dose study is not adequate to rule out th ...
Peripheral Neuropathy Induced by Microtubule
... distribution and is most severe on plantar surfaces.62 The severity of most symptoms is mild to moderate, and symptoms generally disappear on cessation of therapy.44,60,63 Acute tingling in fingertips and toes may occur within 24 hours after paclitaxel infusion.62 Paroxystic pain reaction seems main ...
... distribution and is most severe on plantar surfaces.62 The severity of most symptoms is mild to moderate, and symptoms generally disappear on cessation of therapy.44,60,63 Acute tingling in fingertips and toes may occur within 24 hours after paclitaxel infusion.62 Paroxystic pain reaction seems main ...
Intrapulmonary drug administration in neonatal and paediatric critical care: a comprehensive review REVIEW
... ABSTRACT: Administration of drugs directly into the respiratory tree first was proposed a long time ago. Surfactant is the paradigmatic example of such therapies. Many other drugs have been used in the same way and further compounds are under investigation for this aim. In the last two decades, desp ...
... ABSTRACT: Administration of drugs directly into the respiratory tree first was proposed a long time ago. Surfactant is the paradigmatic example of such therapies. Many other drugs have been used in the same way and further compounds are under investigation for this aim. In the last two decades, desp ...
Administration of Corticosterone After the First Downshift Trial
... CORTICOSTERONE AND CONTRAST 2002). Under the conditions used in the present experiments, goal-tracking time yields data with less individual variability than the more typical licking frequency measure. Procedure. Rats were randomly assigned to one of four groups (n ⫽ 12). Groups differed in terms o ...
... CORTICOSTERONE AND CONTRAST 2002). Under the conditions used in the present experiments, goal-tracking time yields data with less individual variability than the more typical licking frequency measure. Procedure. Rats were randomly assigned to one of four groups (n ⫽ 12). Groups differed in terms o ...
Public Summary Document (Word 458 KB)
... Have previously received docetaxel and are candidates for further active treatment, Have not previously been treated with docetaxel, but are candidates for further active treatment, Are not candidates for any of the currently available active therapies. ...
... Have previously received docetaxel and are candidates for further active treatment, Have not previously been treated with docetaxel, but are candidates for further active treatment, Are not candidates for any of the currently available active therapies. ...
... measures. Most studies involve single referral centers using cross-sectional and retrospective analyses of small numbers of patients with treatment-refractory disease observed for relatively short time periods. In addition, widely disparate inclusion criteria have complicated the assessment of treat ...