Using Sequential, Multiple Assignment, Randomized Trial (SMART
... the critical decisions involved in the adaptive intervention. Each participant moves through the multiple stages and at each stage the participant is randomly (re)assigned to one of several intervention options. As in standard intervention trials, the randomization allows scientists to make valid ca ...
... the critical decisions involved in the adaptive intervention. Each participant moves through the multiple stages and at each stage the participant is randomly (re)assigned to one of several intervention options. As in standard intervention trials, the randomization allows scientists to make valid ca ...
Pfizer Guitly of Violating California Unfair Competition Law
... Neurontin’s efficacy in the published literature, while suppressing negative evidence from Pfizer-sponsored clinical trials about Neurontin’s efficacy for bipolar disorder, neuropathic pain, migraine, and at doses greater than 1800 mg/day. ...
... Neurontin’s efficacy in the published literature, while suppressing negative evidence from Pfizer-sponsored clinical trials about Neurontin’s efficacy for bipolar disorder, neuropathic pain, migraine, and at doses greater than 1800 mg/day. ...
Australian public assessment Report for Abiraterone Acetate
... 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. ...
GTx, Inc. - corporate
... Memphis, Tennessee, is a biopharmaceutical company dedicated to the discovery, development and commercialization of small molecules for the treatment of cancer, including treatments for breast and prostate cancer, and other serious medical conditions. The Company is developing selective androgen rec ...
... Memphis, Tennessee, is a biopharmaceutical company dedicated to the discovery, development and commercialization of small molecules for the treatment of cancer, including treatments for breast and prostate cancer, and other serious medical conditions. The Company is developing selective androgen rec ...
recommendations - Toward Optimized Practice
... and shedding,33 which results in narrowing of the subglottic region. Children compensate for narrowing of upper airway by breathing more rapidly and deeply. As the narrowing progresses, the child’s increased effort to breathe becomes counterproductive. Airflow through the upper airway becomes turbul ...
... and shedding,33 which results in narrowing of the subglottic region. Children compensate for narrowing of upper airway by breathing more rapidly and deeply. As the narrowing progresses, the child’s increased effort to breathe becomes counterproductive. Airflow through the upper airway becomes turbul ...
Neuromodulators and Injectable Fillers
... Administration of the injectable should be simple, reproducible, consistent, without migration, and safe. Patients should have minimal side effects, predictable outcomes, and minimal downtime. The product should also be practical, affordable, versatile, easily stored, and have a durable shelf life.1 ...
... Administration of the injectable should be simple, reproducible, consistent, without migration, and safe. Patients should have minimal side effects, predictable outcomes, and minimal downtime. The product should also be practical, affordable, versatile, easily stored, and have a durable shelf life.1 ...
Hypericum for Depression
... reaching remission of illness was significantly higher with hypericum than with placebo, though the overall success rates were very low (14.3% for SJW; 5% for placebo). Another 8-week study from 2002 made a similar suboptimal dosing error, and subsequently deemed hypericum to be ineffective. A valua ...
... reaching remission of illness was significantly higher with hypericum than with placebo, though the overall success rates were very low (14.3% for SJW; 5% for placebo). Another 8-week study from 2002 made a similar suboptimal dosing error, and subsequently deemed hypericum to be ineffective. A valua ...
Zmax SR Monograph, CPS 2011 - Canadian Pharmacists Association
... Nursing Women: Azithromycin has been reported to have been secreted into human breast milk, but there are no adequate and well-controlled clinical studies in nursing women that have characterized the pharmacokinetics of azithromycin excretion into human breast milk. In addition, the safety of azithr ...
... Nursing Women: Azithromycin has been reported to have been secreted into human breast milk, but there are no adequate and well-controlled clinical studies in nursing women that have characterized the pharmacokinetics of azithromycin excretion into human breast milk. In addition, the safety of azithr ...
Surgical decompression for space-occupying hemispheric infarction Jeannette Hofmeijer
... onset of transient or permanent focal cerebral ischemia reduced edema formation or ischemic damage.21-31 In a recent study, a trend towards a dose-dependent decrease in the water content of the ischemic middle cerebral artery (MCA) cortex and infarcted hemisphere was found. However, relatively more ...
... onset of transient or permanent focal cerebral ischemia reduced edema formation or ischemic damage.21-31 In a recent study, a trend towards a dose-dependent decrease in the water content of the ischemic middle cerebral artery (MCA) cortex and infarcted hemisphere was found. However, relatively more ...
Product Monograph
... pharmacokinetic interaction. Although TOPAMAX® is not indicated for use in patients under two years of age, in an investigational trial in this population, VPA clearly produced a dose-related increase in the incidence of treatment-emergent hyperammonemia (above the upper limit of normal, placebo: 0% ...
... pharmacokinetic interaction. Although TOPAMAX® is not indicated for use in patients under two years of age, in an investigational trial in this population, VPA clearly produced a dose-related increase in the incidence of treatment-emergent hyperammonemia (above the upper limit of normal, placebo: 0% ...
AusPAR: Pitavastatin - 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. ...
Something out of nothing: the placebo effect
... the limelight. The reasons for this are complex, but they probably include the increased use of neuro imaging, the clinical improvement noted in placebo groups in trials of antidepressants, and the growing public and research interest in alternative medicine. Yet placebos have been an enigmatic phe ...
... the limelight. The reasons for this are complex, but they probably include the increased use of neuro imaging, the clinical improvement noted in placebo groups in trials of antidepressants, and the growing public and research interest in alternative medicine. Yet placebos have been an enigmatic phe ...
Guidelines on Neonatal Seizures - International League Against
... abnormality in newborn period and often represent the first sign of neurological dysfunction in neonates. They may be symptomatic or cryptogenic, herald subsequent epilepsy, can be associated with potential morbidity and mortality, and may be used as a factor in considering long-term prognosis. Desp ...
... abnormality in newborn period and often represent the first sign of neurological dysfunction in neonates. They may be symptomatic or cryptogenic, herald subsequent epilepsy, can be associated with potential morbidity and mortality, and may be used as a factor in considering long-term prognosis. Desp ...
Cobicistat / Tenofovir disoproxil fumarate / Emtricitabine / Elvitegravir
... 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. ...
... 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. ...
CASE 4-16180/-JCIP APPENDIX F
... Advised the agency of improprieties discovered during a routine review of the study records at Dr. Berenson’s site where he is conducting a study according to Protocol 1303. ...
... Advised the agency of improprieties discovered during a routine review of the study records at Dr. Berenson’s site where he is conducting a study according to Protocol 1303. ...
Australian Public Assessment Report for Pembrolizumab (rch)
... MSD sought an indication in patients previously treated with ipilimumab; but the FDA required; in addition disease progression following BRAF inhibition in patients with BRAF mutant tumours. The FDA had access to a dataset with an efficacy cut-off date 13 October 2013, but did not have access to sub ...
... MSD sought an indication in patients previously treated with ipilimumab; but the FDA required; in addition disease progression following BRAF inhibition in patients with BRAF mutant tumours. The FDA had access to a dataset with an efficacy cut-off date 13 October 2013, but did not have access to sub ...
FOP - The IFOPA
... and FOP Family Gathering in celebrated its Orlando, Florida 25th Anniversary with a patient and family gathering in Orlando, Florida. Fifty-nine patients and over 279 individuals attended including patients, doctors, researchers, families, friends, and representatives of pharmaceutical companies fro ...
... and FOP Family Gathering in celebrated its Orlando, Florida 25th Anniversary with a patient and family gathering in Orlando, Florida. Fifty-nine patients and over 279 individuals attended including patients, doctors, researchers, families, friends, and representatives of pharmaceutical companies fro ...
Final Protocol - Word 1986 KB - Medical Services Advisory Committee
... (OCT) for the determination of patient eligibility and for efficacy assessment of a single treatment with ocriplasmin (JETREA®). Patients are not eligible for re-treatment with ocriplasmin and as such, monitoring of patients for subsequent treatment will not be required. Patients who do not respond ...
... (OCT) for the determination of patient eligibility and for efficacy assessment of a single treatment with ocriplasmin (JETREA®). Patients are not eligible for re-treatment with ocriplasmin and as such, monitoring of patients for subsequent treatment will not be required. Patients who do not respond ...
Extract from the Clinical Evaluation Report for Ingenol Mebutate
... vehicle-controlled, parallel-group studies, and were the pivotal studies for this indication. PEP005015 was a dose-ranging study that included the proposed dosage regimen treatment on head locations. PEP005-016 and PEP005-025 were Phase III studies that evaluated the proposed dosage regimen of Picat ...
... vehicle-controlled, parallel-group studies, and were the pivotal studies for this indication. PEP005015 was a dose-ranging study that included the proposed dosage regimen treatment on head locations. PEP005-016 and PEP005-025 were Phase III studies that evaluated the proposed dosage regimen of Picat ...
AusPAR: Ibuprofen - Therapeutic Goods Administration
... The proposed MRHD for IV ibuprofen (3200 mg/day) is 33% greater than the MRHD for PO ibuprofen in Australia (2400 mg/day). The clinical exposure data indicate that the plasma AUC was approximately 800 µg.h/mL at the 3200 mg/day IV dose and approximately 600 µg.h/mL at the 2400 mg/day PO dose (Table ...
... The proposed MRHD for IV ibuprofen (3200 mg/day) is 33% greater than the MRHD for PO ibuprofen in Australia (2400 mg/day). The clinical exposure data indicate that the plasma AUC was approximately 800 µg.h/mL at the 3200 mg/day IV dose and approximately 600 µg.h/mL at the 2400 mg/day PO dose (Table ...
french national networks for rare cancers in adults
... A regional clinical expert centre is responsible for adapting these roles at regional level, including organising a regional referral multidisciplinary consultative meeting, enrolling patients in clinical trials, training health professionals at regional level, and developing coordination with heal ...
... A regional clinical expert centre is responsible for adapting these roles at regional level, including organising a regional referral multidisciplinary consultative meeting, enrolling patients in clinical trials, training health professionals at regional level, and developing coordination with heal ...
AVT Figure template - International Medical Press
... Interactions with NNRTIs differ considerably amongst ...
... Interactions with NNRTIs differ considerably amongst ...
Interventional Radiology Curriculum
... investigation and image guided therapeutic management of vascular and non-vascular disease. From the training point of view, Interventional Radiology should be seen as a discipline that synthesises the many complex invasive therapeutic skills, which have developed within all branches of radiology. T ...
... investigation and image guided therapeutic management of vascular and non-vascular disease. From the training point of view, Interventional Radiology should be seen as a discipline that synthesises the many complex invasive therapeutic skills, which have developed within all branches of radiology. T ...
REDMAN_2016 - DUT Open Scholar Home
... dysfunction, capsular syndromes, neurological conditions, arthritides and other). These were then constructed using two-by-two tables for the absence or presence of radiographic diagnoses versus the suspected clinical diagnosis. The McNemars chi square test was used to determine any association betw ...
... dysfunction, capsular syndromes, neurological conditions, arthritides and other). These were then constructed using two-by-two tables for the absence or presence of radiographic diagnoses versus the suspected clinical diagnosis. The McNemars chi square test was used to determine any association betw ...