For Trials Journal
... to GHB/GBL’s rapid elimination (T1/2 ~ 27min) and may also occur during recovery from acute intoxication (overdose) [2, 11,18,19]. A proportion of the patients with GHB dependence may therefore use alcohol or other drugs such as benzodiazepines, “Z Drugs” (e.g. zopiclone) and/or baclofen to self-man ...
... to GHB/GBL’s rapid elimination (T1/2 ~ 27min) and may also occur during recovery from acute intoxication (overdose) [2, 11,18,19]. A proportion of the patients with GHB dependence may therefore use alcohol or other drugs such as benzodiazepines, “Z Drugs” (e.g. zopiclone) and/or baclofen to self-man ...
Limitations of Trauma-Focused Therapies for Treating
... is a moderate effect. Of outmost clinical significance, the difference in PTSD severity scores on the CAPS found at post‐test vanished at 6‐month follow‐up (for analyses conducted on all participants and on completers only); rates of PTSD remission were 40% in PE and 33% in present‐focused therap ...
... is a moderate effect. Of outmost clinical significance, the difference in PTSD severity scores on the CAPS found at post‐test vanished at 6‐month follow‐up (for analyses conducted on all participants and on completers only); rates of PTSD remission were 40% in PE and 33% in present‐focused therap ...
Thyroxine Sodium - 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. ...
Australian public assessment for Thyroxine Sodium
... 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. ...
E - Morgan Joseph
... Pozen’s Trexima will likely replace GlaxoSmithKline’s $1.1bn Imitrex franchise. Key to Pozen’s success is the commercialization of its lead product candidate, Trexima, currently under FDA review with a decision (PDUFA) date of August 1st. A combination product of naproxen sodium (Aleve) and GlaxoSmi ...
... Pozen’s Trexima will likely replace GlaxoSmithKline’s $1.1bn Imitrex franchise. Key to Pozen’s success is the commercialization of its lead product candidate, Trexima, currently under FDA review with a decision (PDUFA) date of August 1st. A combination product of naproxen sodium (Aleve) and GlaxoSmi ...
Probiotics in high-risk preterm infants to prevent necrotizing
... Since the first version of this Trust Guideline was published (2012) an important study of probiotics in neonates has concluded, the UK PiPS trial (https://www.npeu.ox.ac.uk/pips). The PiPS trial is to date the largest and best conducted multi-centre study of probiotics in neonates. This high-qualit ...
... Since the first version of this Trust Guideline was published (2012) an important study of probiotics in neonates has concluded, the UK PiPS trial (https://www.npeu.ox.ac.uk/pips). The PiPS trial is to date the largest and best conducted multi-centre study of probiotics in neonates. This high-qualit ...
6 Topiramate for the Management of Seizures in Children
... early as 1995,2 the drug has only recently been approved for children as young as 2 years of age. There are now a number of studies of this drug in the pediatric population, highlighting both its efficacy and the growing concern over its adverse effect profile. ...
... early as 1995,2 the drug has only recently been approved for children as young as 2 years of age. There are now a number of studies of this drug in the pediatric population, highlighting both its efficacy and the growing concern over its adverse effect profile. ...
Antihistamines in the treatment of chronic urticaria
... Chronic urticaria is highly prevalent in the general population, and while there are multiple treatments for the disorder, the results obtained are not completely satisfactory. The second-generation H1 antihistamines remain the symptomatic treatment option of choice. Depending on the different pharm ...
... Chronic urticaria is highly prevalent in the general population, and while there are multiple treatments for the disorder, the results obtained are not completely satisfactory. The second-generation H1 antihistamines remain the symptomatic treatment option of choice. Depending on the different pharm ...
avodart - Urological Sciences Research Foundation
... Metabolism and Elimination: Dutasteride is extensively metabolized in humans. While not all metabolic pathways have been identified, in vitro studies showed that dutasteride is metabolized by the CYP3A4 isoenzyme to 2 minor mono-hydroxylated metabolites. Dutasteride is not metabolized in vitro by h ...
... Metabolism and Elimination: Dutasteride is extensively metabolized in humans. While not all metabolic pathways have been identified, in vitro studies showed that dutasteride is metabolized by the CYP3A4 isoenzyme to 2 minor mono-hydroxylated metabolites. Dutasteride is not metabolized in vitro by h ...
HALLS DRY COUGH LOZENGES PL 00094/0248 UKPAR TABLE
... pharmacy-only medicine and can be purchased at pharmacies under the supervision of a pharmacist. The product contains the active ingredient, dextromethorphan hydrobromide, which is a cough suppressant; it exerts its antitussive activity by acting on the cough centre of the medulla oblongata. This ap ...
... pharmacy-only medicine and can be purchased at pharmacies under the supervision of a pharmacist. The product contains the active ingredient, dextromethorphan hydrobromide, which is a cough suppressant; it exerts its antitussive activity by acting on the cough centre of the medulla oblongata. This ap ...
Australian Public Assessment Report for Multi
... months to 2 years are at greatest risk of this lethal disease. In Australia, the majority of cases of invasive meningococcal disease (IMD) have been shown to be caused by N. meningitidis serogroup B. According to the National Notifiable Diseases Surveillance System there were 259 notifications of IM ...
... months to 2 years are at greatest risk of this lethal disease. In Australia, the majority of cases of invasive meningococcal disease (IMD) have been shown to be caused by N. meningitidis serogroup B. According to the National Notifiable Diseases Surveillance System there were 259 notifications of IM ...
LBA5000 Oral Abstract Session, Sun, 8:00 AM-11:00 AM
... Julia E. Reid, Gabrielle Fisher, Jerry S. Lanchbury, Alexander Gutin, Steven Stone, Peter Carroll, Transatlantic Prostate Group; Myriad Genetics and Laboratories, Inc., Salt Lake City, UT; Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, London, United Kingdom; University of C ...
... Julia E. Reid, Gabrielle Fisher, Jerry S. Lanchbury, Alexander Gutin, Steven Stone, Peter Carroll, Transatlantic Prostate Group; Myriad Genetics and Laboratories, Inc., Salt Lake City, UT; Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, London, United Kingdom; University of C ...
PRODUCT MONOGRAPH Pr LAMISIL® Terbinafine tablets 250 mg
... Women of child-bearing potential: Some cases of menstrual irregularities have been reported in patients taking LAMISIL tablets concomitantly with oral contraceptives, although the incidence of these disorders remains within the background incidence of patients taking oral contraceptives alone. There ...
... Women of child-bearing potential: Some cases of menstrual irregularities have been reported in patients taking LAMISIL tablets concomitantly with oral contraceptives, although the incidence of these disorders remains within the background incidence of patients taking oral contraceptives alone. There ...
Montelukast versus inhaled corticosteroids in the management of
... 75 (67.40–88.47) % for MLK (p = 0.44). There was similar improvement also in clinical symptom scores and not statistically significant difference between the groups in the need for rescue drugs as well as side effects reported by parents [46]. The study of Kooi et al. [48] was the first, and to date ...
... 75 (67.40–88.47) % for MLK (p = 0.44). There was similar improvement also in clinical symptom scores and not statistically significant difference between the groups in the need for rescue drugs as well as side effects reported by parents [46]. The study of Kooi et al. [48] was the first, and to date ...
Limitations of Trauma-Focused Therapies for Treating
... post-test. In comparison to a wait-list control, an effect size of 0.98 was obtained at post-test, a result somewhat comparable to those of Bradley et al. (2005). In this meta-analysis, EMDR was compared to other exposure techniques and it was found to be equally efficacious, no more. Finally, whet ...
... post-test. In comparison to a wait-list control, an effect size of 0.98 was obtained at post-test, a result somewhat comparable to those of Bradley et al. (2005). In this meta-analysis, EMDR was compared to other exposure techniques and it was found to be equally efficacious, no more. Finally, whet ...
Antibiotic therapy for Shigella dysentery (Review) The Cochrane Library 2010, Issue 8
... 1.1 million deaths per year globally, mostly in children under five years. The intention of giving antibiotics in shigellosis is to speed recovery, reduce the seriousness of the disease, and reduce the length of time patients are infective. However, some antibiotics can have serious side effects whi ...
... 1.1 million deaths per year globally, mostly in children under five years. The intention of giving antibiotics in shigellosis is to speed recovery, reduce the seriousness of the disease, and reduce the length of time patients are infective. However, some antibiotics can have serious side effects whi ...
Regulatory requirements for the development of medicinal products
... always necessary to support an indication in this population age-appropriate, normal laboratory values and clinical measurements should be used in such studies. long-term studies or surveillance data (chronic therapy or during the posttherapy period) may be needed to determine possible effects on sk ...
... always necessary to support an indication in this population age-appropriate, normal laboratory values and clinical measurements should be used in such studies. long-term studies or surveillance data (chronic therapy or during the posttherapy period) may be needed to determine possible effects on sk ...
navigate x4 - clinical summary
... endpoint was evaluated at 3 months post-implant. X4 Cohorts 1 and 2 will be analyzed together. For this endpoint, responders will be defined as subjects with PCT ≤ 2.5 V in the programmed configuration. The hypothesis for this endpoint is that the 3 month responder rate will be greater than 75%. • ...
... endpoint was evaluated at 3 months post-implant. X4 Cohorts 1 and 2 will be analyzed together. For this endpoint, responders will be defined as subjects with PCT ≤ 2.5 V in the programmed configuration. The hypothesis for this endpoint is that the 3 month responder rate will be greater than 75%. • ...
Guidelines on the practice of ethics committees 4th ed
... Anyone who contemplates a medical study involving human subjects has to gain approval from an independent research ethics committee. This is the equivalent of throwing a six to start navigating the increasingly complicated regulatory environment in which clinical trials and other studies presently t ...
... Anyone who contemplates a medical study involving human subjects has to gain approval from an independent research ethics committee. This is the equivalent of throwing a six to start navigating the increasingly complicated regulatory environment in which clinical trials and other studies presently t ...
- Wiley Online Library
... It is not feasible to distinguish recurrence due to relapse (renewed symptoms from already present CDI) from recurrence due to reinfection in daily practice [20,25–28]. ...
... It is not feasible to distinguish recurrence due to relapse (renewed symptoms from already present CDI) from recurrence due to reinfection in daily practice [20,25–28]. ...
Case Study Findings Report
... critical, as it allowed for the coordination of several groups with different primary interests to work towards the same common goal. This was facilitated by the credibility of the CTG investigators and the perception that it was not tied too closely to any specific scientific interests. As such, th ...
... critical, as it allowed for the coordination of several groups with different primary interests to work towards the same common goal. This was facilitated by the credibility of the CTG investigators and the perception that it was not tied too closely to any specific scientific interests. As such, th ...
Pharmacological interventions for preventing post
... PTSD (risk ratio (RR) 0.17; 95% confidence interval (CI) 0.05 to 0.56; P value = 0.004), indicating that between seven and 13 patients would need to be treated with this agent in order to prevent the onset of PTSD in one patient. There was low quality evidence for preventing the onset of PTSD in thr ...
... PTSD (risk ratio (RR) 0.17; 95% confidence interval (CI) 0.05 to 0.56; P value = 0.004), indicating that between seven and 13 patients would need to be treated with this agent in order to prevent the onset of PTSD in one patient. There was low quality evidence for preventing the onset of PTSD in thr ...
P.O. Box 144345 Austin, TX 78714
... (cyanidin-3-glucoside and cyanidin-3-sambubioside), hemagglutinin protein Sambucus nigra agglutinin III (SNA-III), cyanogenic glycosides (including sambunigrin), viburnic acid, and vitamins A and C. The pharmacokinetics of many of these constituents are not completely understood. Research has focuse ...
... (cyanidin-3-glucoside and cyanidin-3-sambubioside), hemagglutinin protein Sambucus nigra agglutinin III (SNA-III), cyanogenic glycosides (including sambunigrin), viburnic acid, and vitamins A and C. The pharmacokinetics of many of these constituents are not completely understood. Research has focuse ...
AusPAR Tiotropium bromide - 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. ...
Clinical Practice Guidelines for Diagnostic Testing
... Moreover, prior guidelines included consensus statements that have not been specifically evaluated in clinical trials. Following careful qualitative evaluation by the TF, some of these statements that were felt to be of high importance to ensure quality care were adopted in the current guideline as ...
... Moreover, prior guidelines included consensus statements that have not been specifically evaluated in clinical trials. Following careful qualitative evaluation by the TF, some of these statements that were felt to be of high importance to ensure quality care were adopted in the current guideline as ...