New Drugs and Formulations: Effect on Therapeutic Paradigms
... • Investigational NNRTI • Pre-clinical –Potent at low milligram dose –Metabolized by CYP3A4; not a CYP450 inhibitor or inducer –Active in vitro against viral strains with: • K103N • Y181C • G190A • E101K •E138K • K103N/Y181C Lai AAC 2014;58:1652-1663 ...
... • Investigational NNRTI • Pre-clinical –Potent at low milligram dose –Metabolized by CYP3A4; not a CYP450 inhibitor or inducer –Active in vitro against viral strains with: • K103N • Y181C • G190A • E101K •E138K • K103N/Y181C Lai AAC 2014;58:1652-1663 ...
eTable 1. Study inclusion and exclusion criteria Inclusion criteria
... The following methods of contraception are considered to be medically acceptable: established use of oral, injected, or implanted hormonal contraception; placement of an intrauterine device or intrauterine system; or use of a barrier method of contraception (condom or occlusive cap with use of a s ...
... The following methods of contraception are considered to be medically acceptable: established use of oral, injected, or implanted hormonal contraception; placement of an intrauterine device or intrauterine system; or use of a barrier method of contraception (condom or occlusive cap with use of a s ...
ACRC Glossary Common Terminology
... includes living human participants, human tissues, human remains, cadavers, biological fluids, embryos, fetuses and patient information. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. This includes clinical trials on patien ...
... includes living human participants, human tissues, human remains, cadavers, biological fluids, embryos, fetuses and patient information. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. This includes clinical trials on patien ...
Progressnotes
... Irving, CA) tightly over a balloon (Figure 1), inserting it via a catheter into the ileofemoral artery and advancing it to the aortic valve. The procedure is performed twice: on the first pass, the balloon is expanded to open up the stenosis and on the second pass the Edward SAPIEN valve is deployed ...
... Irving, CA) tightly over a balloon (Figure 1), inserting it via a catheter into the ileofemoral artery and advancing it to the aortic valve. The procedure is performed twice: on the first pass, the balloon is expanded to open up the stenosis and on the second pass the Edward SAPIEN valve is deployed ...
Afrezza®: Inhaled insulin approved by the FDA
... • One trial (102) with MedTone: subjects on prior insulin therapy : ...
... • One trial (102) with MedTone: subjects on prior insulin therapy : ...
Hydrocortisone - Queensland Ambulance Service
... Under no circumstances will the QAS, its employees or agents, be liable for any loss, injury, claim, liability or damages of any kind resulting from the unauthorised use of, or reliance upon the CPM or its contents. While effort has been made to contact all copyright owners this has not always been ...
... Under no circumstances will the QAS, its employees or agents, be liable for any loss, injury, claim, liability or damages of any kind resulting from the unauthorised use of, or reliance upon the CPM or its contents. While effort has been made to contact all copyright owners this has not always been ...
Injectable Soft-Tissue Fillers: Clinical Overview
... test. Unlike bovine collagen implants, these dermal fillers do not require a pretreatment skin test before treatment. This has been established through their preapproval U.S. Food and Drug Administration application study. Thus, patients may undergo treatment at the time of their initial consultatio ...
... test. Unlike bovine collagen implants, these dermal fillers do not require a pretreatment skin test before treatment. This has been established through their preapproval U.S. Food and Drug Administration application study. Thus, patients may undergo treatment at the time of their initial consultatio ...
Glucosamine May Reduce Pain in Individuals with Knee Osteoarthritis
... controlled study of 212 patients with knee OA. The original study evaluated the effects of glucosamine sulfate on symptom and structure modification in knee OA. Outcome measure: Computer-assisted radiographic joint space width (JSW) and joint space narrowing (JSN). Results: In the placebo group JSW ...
... controlled study of 212 patients with knee OA. The original study evaluated the effects of glucosamine sulfate on symptom and structure modification in knee OA. Outcome measure: Computer-assisted radiographic joint space width (JSW) and joint space narrowing (JSN). Results: In the placebo group JSW ...
Using Workflows to Standardize Business Processes and Best Practices in Pharmaceutical Programming
... create an abstraction of all activities that balances control with flexibility to deviate from the specification if needed. In most cases this abstraction results in a simplification of reality. WORKFLOW MANAGEMENT SYSTEM ...
... create an abstraction of all activities that balances control with flexibility to deviate from the specification if needed. In most cases this abstraction results in a simplification of reality. WORKFLOW MANAGEMENT SYSTEM ...
A Resource and Data Quality Comparison : Absolute Bioavailability
... A therapeutically relevant dose is formulated for IV dosing. The aim is to produce a similar level of exposure as is likely to be experienced from the oral dose. However, as the human Fabs is unknown, this may not be achieved. Blood samples are taken over a designated time period, analysed for examp ...
... A therapeutically relevant dose is formulated for IV dosing. The aim is to produce a similar level of exposure as is likely to be experienced from the oral dose. However, as the human Fabs is unknown, this may not be achieved. Blood samples are taken over a designated time period, analysed for examp ...
BioInvent Interim Report 1 January – 30 June 2015
... In January 2015 BioInvent entered into an agreement with Cancer Research UK (CRUK), Cancer Research Technology (CRT) and Leukaemia & Lymphoma Research (LLR) on implementation of a phase I/II study with BI-1206 in patients with CLL and NHL. The first study in patients will be financed and executed by ...
... In January 2015 BioInvent entered into an agreement with Cancer Research UK (CRUK), Cancer Research Technology (CRT) and Leukaemia & Lymphoma Research (LLR) on implementation of a phase I/II study with BI-1206 in patients with CLL and NHL. The first study in patients will be financed and executed by ...
Monitoring of Liver Function Tests in Patients - PCSS-MAT
... not associated with discontinuation of study medication, include insomnia, nausea, vomiting, and headache (Revia® and Vivitrol® package inserts). Overall NTX and XR-NTX are documented safe, clinically efficacious FDA-approved medications to assist in treatment of opioid and alcohol use disorders (Ga ...
... not associated with discontinuation of study medication, include insomnia, nausea, vomiting, and headache (Revia® and Vivitrol® package inserts). Overall NTX and XR-NTX are documented safe, clinically efficacious FDA-approved medications to assist in treatment of opioid and alcohol use disorders (Ga ...
Methodological issues in therapeutic trials of COPD PERSPECTIVE
... from 26% in the study by SZAFRANSKI et al. [6] to 51% in the TORCH trial, and reached as much as 77% in the Optimal trial. In all these trials, the patients were, of course, required to stop their ICSs at the time of randomisation. This unusual situation creates a unique challenge in interpretation. ...
... from 26% in the study by SZAFRANSKI et al. [6] to 51% in the TORCH trial, and reached as much as 77% in the Optimal trial. In all these trials, the patients were, of course, required to stop their ICSs at the time of randomisation. This unusual situation creates a unique challenge in interpretation. ...
2013 European guideline for the management of balanoposthitis
... Zoon’s balanitis is a disease of older men who are uncircumcised. It is thought to be due to irritation, partially caused by urine, in the context of a ‘dysfunctional prepuce.’ It is generally regarded as a benign condition. Zoonoid inflammation clinically and histologically very frequently complicat ...
... Zoon’s balanitis is a disease of older men who are uncircumcised. It is thought to be due to irritation, partially caused by urine, in the context of a ‘dysfunctional prepuce.’ It is generally regarded as a benign condition. Zoonoid inflammation clinically and histologically very frequently complicat ...
Core Aspects of Clinical Development and Trials in Chronic
... in CIC is to thoroughly document a drug profile with an acceptable balance between efficacy and safety. The use of opioids and the side effects of opioid use have reached near epidemic proportions in the United States. The prevalence of constipation in this population is estimated to range between 2 ...
... in CIC is to thoroughly document a drug profile with an acceptable balance between efficacy and safety. The use of opioids and the side effects of opioid use have reached near epidemic proportions in the United States. The prevalence of constipation in this population is estimated to range between 2 ...
Lutinus vaginal tablet ENG SmPC
... Because progesterone may cause some degree of fluid retention, conditions that might be influenced by this factor (e.g. epilepsy, migraine, asthma, cardiac or renal dysfunction) require careful observation. A decrease in insulin sensitivity and thereby in glucose tolerance has been observed in a sma ...
... Because progesterone may cause some degree of fluid retention, conditions that might be influenced by this factor (e.g. epilepsy, migraine, asthma, cardiac or renal dysfunction) require careful observation. A decrease in insulin sensitivity and thereby in glucose tolerance has been observed in a sma ...
Novel oral anticoagulants and reversal agents
... warfarin, even without reversal agents. Still, it was broadly accepted that it would be helpful to have reversal agents available for clinicians to use. Because it is not feasible to do definitive outcomes studies demonstrating a reversal agent's clinical benefits, it was felt that these agents coul ...
... warfarin, even without reversal agents. Still, it was broadly accepted that it would be helpful to have reversal agents available for clinicians to use. Because it is not feasible to do definitive outcomes studies demonstrating a reversal agent's clinical benefits, it was felt that these agents coul ...
Examining the Systemic Safety of Anti-VEGF Agents
... however, analysis of the highest dose group, monthly 0.5 mg ranibizumab or 2.0 mg aflibercept, showed a threefold increased risk of death over sham (P = .003). The risk of stroke and vascular death was also elevated in this group, but only to a borderline significant level. Again, the results were f ...
... however, analysis of the highest dose group, monthly 0.5 mg ranibizumab or 2.0 mg aflibercept, showed a threefold increased risk of death over sham (P = .003). The risk of stroke and vascular death was also elevated in this group, but only to a borderline significant level. Again, the results were f ...
The Art and Science of Traditional Medicine Part 2: Multidisciplinary
... ILLUSTRATION (FRONT) CHARLOTTE LOKIN ...
... ILLUSTRATION (FRONT) CHARLOTTE LOKIN ...
Drug Safety Surveillance: Modern Trends and Industrial Action
... time undergone by the drug during premarketing studies as well as the bias by the pharmaceutical-industries to get approval from regulatory-agencies. As a result of this many safety data and information are lacking. Therefore, in order to preserve patient confidence and integrity of pharmaceutical p ...
... time undergone by the drug during premarketing studies as well as the bias by the pharmaceutical-industries to get approval from regulatory-agencies. As a result of this many safety data and information are lacking. Therefore, in order to preserve patient confidence and integrity of pharmaceutical p ...
Diffuse unilateral subacute neuroretinitis in a young boy: a case report
... oral prednisolone 1 mg/kg with tapering doses over 6 weeks. At 1 month follow-up, the inflammation had reduced, and multiple, focal, gray-white subretinal lesions were resolved; however there was no improvement of vision. ...
... oral prednisolone 1 mg/kg with tapering doses over 6 weeks. At 1 month follow-up, the inflammation had reduced, and multiple, focal, gray-white subretinal lesions were resolved; however there was no improvement of vision. ...
Guidance for Industry Acne Vulgaris: Developing Drugs for Treatment DRAFT GUIDANCE
... This document is intended to provide guidance to the pharmaceutical industry on the development of drug products for the treatment of acne vulgaris other than nodulocystic acne. The information presented will help applicants plan clinical studies, design clinical protocols, implement and appropriate ...
... This document is intended to provide guidance to the pharmaceutical industry on the development of drug products for the treatment of acne vulgaris other than nodulocystic acne. The information presented will help applicants plan clinical studies, design clinical protocols, implement and appropriate ...
Investigator Notification for Nivolumab and Ipilimumab
... resonance tomography (MRT), audiogram and consultation with neurologist. Results pending. At the time of reporting, the event of autoimmune disorder was ongoing. Medical history included vitamin B12 deficiency, diabetes, colon cancer, gastritis, impaired hearing (since 2014), sigmoid thrombus of tra ...
... resonance tomography (MRT), audiogram and consultation with neurologist. Results pending. At the time of reporting, the event of autoimmune disorder was ongoing. Medical history included vitamin B12 deficiency, diabetes, colon cancer, gastritis, impaired hearing (since 2014), sigmoid thrombus of tra ...
OMNICEF® (cefdinir) capsules (cefdinir) for oral suspension
... Staphylococcus aureus (including β-lactamase producing strains) NOTE: Cefdinir is inactive against methicillin-resistant staphylococci. Streptococcus pneumoniae (penicillin-susceptible strains only) ...
... Staphylococcus aureus (including β-lactamase producing strains) NOTE: Cefdinir is inactive against methicillin-resistant staphylococci. Streptococcus pneumoniae (penicillin-susceptible strains only) ...