medications may be stopped for Crohn`s disease patients in remission
... 29% on placebo maintained remission 3 Injections + Placebo ...
... 29% on placebo maintained remission 3 Injections + Placebo ...
The use of bedaquiline in the treatment of multidrug-resistant
... The emergence of drug resistance is a major threat to global tuberculosis (TB) care and control. The World Health Organization (WHO) estimates that up to half a million new cases of multidrug-resistant tuberculosis (MDR-TB) cases (i.e. resistant to, at least, rifampicin and isoniazid) occur each yea ...
... The emergence of drug resistance is a major threat to global tuberculosis (TB) care and control. The World Health Organization (WHO) estimates that up to half a million new cases of multidrug-resistant tuberculosis (MDR-TB) cases (i.e. resistant to, at least, rifampicin and isoniazid) occur each yea ...
Prescribing Information
... The indication for adult use is based on Week 48 analyses from 2 randomized, double-blind, placebo-controlled trials of INTELENCE®. Both studies were conducted in clinically advanced, 3-class antiretroviral (NNRTI, N[t]RTI, PI) treatment-experienced adults. The indication for pediatric use is based ...
... The indication for adult use is based on Week 48 analyses from 2 randomized, double-blind, placebo-controlled trials of INTELENCE®. Both studies were conducted in clinically advanced, 3-class antiretroviral (NNRTI, N[t]RTI, PI) treatment-experienced adults. The indication for pediatric use is based ...
AusPAR: Lipegfilgrastim - Therapeutic Goods Administration
... count in some conditions and has been used in cancer to reduce neutropenia, a risk factor for infection and for increasing delay in the next chemotherapy cycle. The sponsor has proposed the following indications for Lonquex: Lonquex is indicated for the treatment of cancer patients following chemoth ...
... count in some conditions and has been used in cancer to reduce neutropenia, a risk factor for infection and for increasing delay in the next chemotherapy cycle. The sponsor has proposed the following indications for Lonquex: Lonquex is indicated for the treatment of cancer patients following chemoth ...
Gene therapy clinical trials: what about the environment?
... In all jurisdictions, gene therapy clinical trials are within the scope of existing regulatory systems that govern human clinical trials or biomedical research. These regulations in the first place aim at the safety of the human subject in the studies. The product-based approach is most apparent in ...
... In all jurisdictions, gene therapy clinical trials are within the scope of existing regulatory systems that govern human clinical trials or biomedical research. These regulations in the first place aim at the safety of the human subject in the studies. The product-based approach is most apparent in ...
Editorial Response: Single Daily Dosing of Aminoglycosides
... time required for resolution of the surrogate markers of infection. These investigators dosed aminoglycosides with use of individualized pharmacokinetic monitoring on an 8-hour, 12hour, or 24-hour schedule, depending on renal function, to optimize the postdistributional Cmax/MIC ratio and limit rena ...
... time required for resolution of the surrogate markers of infection. These investigators dosed aminoglycosides with use of individualized pharmacokinetic monitoring on an 8-hour, 12hour, or 24-hour schedule, depending on renal function, to optimize the postdistributional Cmax/MIC ratio and limit rena ...
PDF - Trials
... the sample size was smaller than 80 clinical cases in two studies [16,17], the biggest one being less than 130 clinical cases [18,19]. In addition, the side effects during acupuncture treatment and the follow-up tests were not reported in any of these trials. The design of the control group was illo ...
... the sample size was smaller than 80 clinical cases in two studies [16,17], the biggest one being less than 130 clinical cases [18,19]. In addition, the side effects during acupuncture treatment and the follow-up tests were not reported in any of these trials. The design of the control group was illo ...
Percutaneous Coronary Intervention Versus
... Background—The role of percutaneous coronary intervention (PCI) in the management of stable coronary artery disease remains controversial. Given advancements in medical therapies and stent technology over the last decade, we sought to evaluate whether PCI, when added to medical therapy, improves out ...
... Background—The role of percutaneous coronary intervention (PCI) in the management of stable coronary artery disease remains controversial. Given advancements in medical therapies and stent technology over the last decade, we sought to evaluate whether PCI, when added to medical therapy, improves out ...
TECFIDERA Product Monograph
... The efficacy of TECFIDERA in patients with primary progressive multiple sclerosis has not been established. TECFIDERA should only be prescribed by clinicians who are experienced in the diagnosis and management of multiple sclerosis. Geriatrics (> 65 years of age): Clinical studies of TECFIDERA did n ...
... The efficacy of TECFIDERA in patients with primary progressive multiple sclerosis has not been established. TECFIDERA should only be prescribed by clinicians who are experienced in the diagnosis and management of multiple sclerosis. Geriatrics (> 65 years of age): Clinical studies of TECFIDERA did n ...
Extract from Clinical Evaluation Report
... advanced cancers including CRC. The first indication was for treatment of patients with metastatic CRC irrespective of KRAS mutational status who have been previously treated with or not considered candidates for Fluoropyrimidine chemotherapy, an anti-VEGF therapy and if KRAS wild type an anti-EGFR ...
... advanced cancers including CRC. The first indication was for treatment of patients with metastatic CRC irrespective of KRAS mutational status who have been previously treated with or not considered candidates for Fluoropyrimidine chemotherapy, an anti-VEGF therapy and if KRAS wild type an anti-EGFR ...
Lesson 4: Pathology and Treatment Options
... o Specimen(s) Received. This section is a description of what specimen was submitted to the pathologist from the surgeon and what procedure was done to obtain it. These are the tissues that will be examined by a pathologist to establish a diagnosis. o Clinical History. This section refers to the pat ...
... o Specimen(s) Received. This section is a description of what specimen was submitted to the pathologist from the surgeon and what procedure was done to obtain it. These are the tissues that will be examined by a pathologist to establish a diagnosis. o Clinical History. This section refers to the pat ...
Delamanid improves outcomes and reduces mortality in multidrug-resistant tuberculosis
... Study 116 was a multicentre, observational study conducted between January 2011 and May 2012 at all 17 sites included in Trial 204, regardless of their participation in Trial 208 (fig. 2). The aim was to capture data for all patients that were randomised in Trial 204, therefore, the sample size was ...
... Study 116 was a multicentre, observational study conducted between January 2011 and May 2012 at all 17 sites included in Trial 204, regardless of their participation in Trial 208 (fig. 2). The aim was to capture data for all patients that were randomised in Trial 204, therefore, the sample size was ...
XIFAXAN Tablets contain rifaximin, a semi-synthetic, nonsystemic antibiotic. The chemical name S
... discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile. ...
... discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile. ...
Master-Thesis
... receipt of a marketing authorisation for a new medicinal product it can take up to 12 – 15 years, or in some cases even longer. For several medicinal products the costs of the complete development program can reach up to $ 1 billion [1–3]. Other experts even expect an average of between $ 4 and $ 11 ...
... receipt of a marketing authorisation for a new medicinal product it can take up to 12 – 15 years, or in some cases even longer. For several medicinal products the costs of the complete development program can reach up to $ 1 billion [1–3]. Other experts even expect an average of between $ 4 and $ 11 ...
Generalities
... GSASA and the European Society of Clinical Pharmacy – ESCP, we are pleased to invite you to the 38th European Symposium on Clinical Pharmacy in Geneva. In 2009, the European Society of Clinical Pharmacy celebrates its 30th anniversary. ESCP was indeed founded in Lyon in 1979 by clinical practitioner ...
... GSASA and the European Society of Clinical Pharmacy – ESCP, we are pleased to invite you to the 38th European Symposium on Clinical Pharmacy in Geneva. In 2009, the European Society of Clinical Pharmacy celebrates its 30th anniversary. ESCP was indeed founded in Lyon in 1979 by clinical practitioner ...
product monograph
... Nursing Women: It is not known whether NEULASTA is excreted in human milk. Because many drugs are excreted in human milk‚ NEULASTA is not recommended for women who are ...
... Nursing Women: It is not known whether NEULASTA is excreted in human milk. Because many drugs are excreted in human milk‚ NEULASTA is not recommended for women who are ...
Going with the Flow - Practical Dermatology
... advanced our understanding of these popular products, and provided a rationale for the product selection strategies, based on instinct and anecdotal experience, that have developed since their introduction. Clinical observations initially gave rise to scientific discovery, but it is now science that ...
... advanced our understanding of these popular products, and provided a rationale for the product selection strategies, based on instinct and anecdotal experience, that have developed since their introduction. Clinical observations initially gave rise to scientific discovery, but it is now science that ...
Drugs for Pulmonary Arterial Hypertension – Project Protocol
... jurisdictional clients. Policy questions will also feed deliberations of the CDEC members when they develop the therapeutic review recommendations. 1) How do new drugs for advanced therapy of PAH compare with currently available drugs? 2) How does (add-on) combination therapy compare with monotherap ...
... jurisdictional clients. Policy questions will also feed deliberations of the CDEC members when they develop the therapeutic review recommendations. 1) How do new drugs for advanced therapy of PAH compare with currently available drugs? 2) How does (add-on) combination therapy compare with monotherap ...
Title Improving clinical trial efficiency by biomarker
... Empirical example of antihypertensive trials with diabetic patients We also evaluated the three designs for a scenario derived from data of two empirical studies. The Reduction in End Points in NIDDM with the Angiotensin II Antagonist Losartan (RENAAL) study and the Irbesartan Diabetic Nephropathy T ...
... Empirical example of antihypertensive trials with diabetic patients We also evaluated the three designs for a scenario derived from data of two empirical studies. The Reduction in End Points in NIDDM with the Angiotensin II Antagonist Losartan (RENAAL) study and the Irbesartan Diabetic Nephropathy T ...
4.3. Contraindications
... and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo. If, based on clinical need, a decision to treat is nevertheless taken, the p ...
... and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo. If, based on clinical need, a decision to treat is nevertheless taken, the p ...
Newsletter Summer 2008
... Pseudomonas aeruginosa, though more research is needed to understand the frequency and impact in CF. If low oxygen is suspected, a physician may order overnight monitoring during hospitalization for a CF tune-up or lung exacerbation. This involves simply attaching a fingertip oxygen monitor and smal ...
... Pseudomonas aeruginosa, though more research is needed to understand the frequency and impact in CF. If low oxygen is suspected, a physician may order overnight monitoring during hospitalization for a CF tune-up or lung exacerbation. This involves simply attaching a fingertip oxygen monitor and smal ...
Careers in pharmaceutical medicine
... world, it may be used in groups of patients who were excluded from clinical development e.g. elderly patients, patients with other co-morbidities, patients with other concomitant medications. Other safety signals may emerge that need to be monitored and categorised with any relevant action being tak ...
... world, it may be used in groups of patients who were excluded from clinical development e.g. elderly patients, patients with other co-morbidities, patients with other concomitant medications. Other safety signals may emerge that need to be monitored and categorised with any relevant action being tak ...
VIEW PDF - Practical Neurology
... primary RLS when given at 1mg before bedtime, but also probably ineffective when given at four doses throughout the day.” Botox. The guidelines note there is “Class III evidence that botox onabotulinumtoxinA improves RLS symptoms during the first 4 weeks after treatment.” The group notes in the prev ...
... primary RLS when given at 1mg before bedtime, but also probably ineffective when given at four doses throughout the day.” Botox. The guidelines note there is “Class III evidence that botox onabotulinumtoxinA improves RLS symptoms during the first 4 weeks after treatment.” The group notes in the prev ...