Australian public assessment for Enzalutamide
... South Korea, amongst a number of countries. Product information The approved Product Information (PI) current at the time this AusPAR was prepared can be found as Attachment 1. For the most recent PI, please refer to the TGA website at.
...
... South Korea, amongst a number of countries. Product information The approved Product Information (PI) current at the time this AusPAR was prepared can be found as Attachment 1. For the most recent PI, please refer to the TGA website at
Product Monograph Template - Standard - GlaxoSmithKline
... the diagnosis. Positive cultures for herpes simplex virus offer the only absolute means for confirmation of the diagnosis. Appropriate examinations should be performed to rule out other sexually transmitted diseases. All patients should be advised to take particular care to avoid potential transmiss ...
... the diagnosis. Positive cultures for herpes simplex virus offer the only absolute means for confirmation of the diagnosis. Appropriate examinations should be performed to rule out other sexually transmitted diseases. All patients should be advised to take particular care to avoid potential transmiss ...
YOSPRALA - aralez pharmaceuticals
... Oval, blue-green, film-coated, delayed-release tablets for oral administration containing either: • 81 mg delayed-release aspirin and 40 mg immediate-release omeprazole, printed with 81/40, or • 325 mg delayed-release aspirin and 40 mg immediate-release omeprazole, printed with ...
... Oval, blue-green, film-coated, delayed-release tablets for oral administration containing either: • 81 mg delayed-release aspirin and 40 mg immediate-release omeprazole, printed with 81/40, or • 325 mg delayed-release aspirin and 40 mg immediate-release omeprazole, printed with ...
Appendix 7 Analysis of 220 papers/letters that cite the Keller paper
... Numerous studies have reported definite therapeutic benefits with selective serotonin reuptake inhibitors (SSRIs) in depressed adolescents (27,28). Available studies show similar rates of clinical response to either psychotherapy or medication (27,31). Either approach would therefore be empirically ...
... Numerous studies have reported definite therapeutic benefits with selective serotonin reuptake inhibitors (SSRIs) in depressed adolescents (27,28). Available studies show similar rates of clinical response to either psychotherapy or medication (27,31). Either approach would therefore be empirically ...
Epzicom Tablets
... myocardial infarction (MI) in patients on combination antiretroviral therapy, the use of abacavir within the previous 6 months was correlated with an increased risk of MI. In a sponsor-conducted pooled analysis of clinical trials, no excess risk of MI was observed in abacavir-treated subjects as com ...
... myocardial infarction (MI) in patients on combination antiretroviral therapy, the use of abacavir within the previous 6 months was correlated with an increased risk of MI. In a sponsor-conducted pooled analysis of clinical trials, no excess risk of MI was observed in abacavir-treated subjects as com ...
European Commission Guidelines on Clinical Audit
... Role of professional and scientific societies..................................................................................................... 10 Practical organizing of clinical audits ............................................................................................................. ...
... Role of professional and scientific societies..................................................................................................... 10 Practical organizing of clinical audits ............................................................................................................. ...
Guidelines on Common Technical Document (CTD)
... registration of pharmaceutical products for human use. The same is already in use for biological products since 2009 and now this guidance document describes the format for preparation of CTD for marketing approval of pharmaceuticals for human use other than biological products (vaccines, biotechnol ...
... registration of pharmaceutical products for human use. The same is already in use for biological products since 2009 and now this guidance document describes the format for preparation of CTD for marketing approval of pharmaceuticals for human use other than biological products (vaccines, biotechnol ...
AusPAR: Ivabradine - 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. ...
european commission
... Role of professional and scientific societies..................................................................................................... 10 Practical organizing of clinical audits ............................................................................................................. ...
... Role of professional and scientific societies..................................................................................................... 10 Practical organizing of clinical audits ............................................................................................................. ...
1 - Case Western Reserve University
... 2. All full-time graduate students will initially be assigned to clinical duties at CHSC for approximately 4-8 hours per week. Part-time students will be assigned to 2-4 hours per week. Once a student has successfully completed approximately 100 contact hours, he/she can be considered for an externs ...
... 2. All full-time graduate students will initially be assigned to clinical duties at CHSC for approximately 4-8 hours per week. Part-time students will be assigned to 2-4 hours per week. Once a student has successfully completed approximately 100 contact hours, he/she can be considered for an externs ...
Cost-Effectiveness Of Bevacizumab Concomitant With The Standard
... Figure 3. A TreeAge diagram of a Markov model used to calculate the cost-effectiveness of BEV added to the standard of care compared to the SOC for newly diagnosed GBM 26 Figure 4. Published and recreated AVAglio clinical trial progression free survival Kaplan-Meier curves of the two treatment arms ...
... Figure 3. A TreeAge diagram of a Markov model used to calculate the cost-effectiveness of BEV added to the standard of care compared to the SOC for newly diagnosed GBM 26 Figure 4. Published and recreated AVAglio clinical trial progression free survival Kaplan-Meier curves of the two treatment arms ...
Priority Topics and Key Features - The College of Family Physicians
... gastroesophageal reflux disease, peptic ulcer disease, ulcerative colitis, Crohn’s disease), manage specific pathology appropriately (e.g., with. medication, lifestyle modifications). ...
... gastroesophageal reflux disease, peptic ulcer disease, ulcerative colitis, Crohn’s disease), manage specific pathology appropriately (e.g., with. medication, lifestyle modifications). ...
View the Conference Brochure - American Association for Clinical
... most cutting edge topics in clinical chemistry, you can visit the exhibits only. Visit www.aacc.org/2016am for details. Expo-only registrations received by June 16, 2016, are only $20. Expo-only registrations received after June 16 or onsite are $40 per person. For a complete listing of where exhibi ...
... most cutting edge topics in clinical chemistry, you can visit the exhibits only. Visit www.aacc.org/2016am for details. Expo-only registrations received by June 16, 2016, are only $20. Expo-only registrations received after June 16 or onsite are $40 per person. For a complete listing of where exhibi ...
Extract from Clinical Evaluation Report: Ruxolitinib
... inflammatory and pro-angiogenic cytokines.6 The clinical features of MF are variable and include progressive anaemia, leucopenia or leucocytosis, thrombocytopenia or thrombocytosis and multi-organ extramedullary haematopoiesis, most commonly resulting in hepatomegaly and symptomatic splenomegaly. Pa ...
... inflammatory and pro-angiogenic cytokines.6 The clinical features of MF are variable and include progressive anaemia, leucopenia or leucocytosis, thrombocytopenia or thrombocytosis and multi-organ extramedullary haematopoiesis, most commonly resulting in hepatomegaly and symptomatic splenomegaly. Pa ...
Aphthous Ulceration
... of the most common oral ailments. The disease is characterized by recurring painful ulcers of the mouth that are round or ovoid and have inflammatory halos. The ulcers typically appear first in childhood (patients often have a family history of recurrent aphthous stomatitis) and tend to abate around ...
... of the most common oral ailments. The disease is characterized by recurring painful ulcers of the mouth that are round or ovoid and have inflammatory halos. The ulcers typically appear first in childhood (patients often have a family history of recurrent aphthous stomatitis) and tend to abate around ...
Zeldox oral suspension ENG SmPC
... Zeldox 10 mg/ml oral suspension contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed). Zeldox 10 mg/ml oral suspension contains 4.65 mg sodium per ml dosed and this should be taken into account in patients on a controlled sodium diet ...
... Zeldox 10 mg/ml oral suspension contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed). Zeldox 10 mg/ml oral suspension contains 4.65 mg sodium per ml dosed and this should be taken into account in patients on a controlled sodium diet ...
Zeldox capsule, hard ENG SmPC
... Increased risk of cerebrovascular accidents in the dementia population An approximately 3-fold increased risk of cerebrovascular adverse events has been seen in randomised placebo-controlled clinical trials in the dementia population with some atypical antipsychotics. The mechanism for this increase ...
... Increased risk of cerebrovascular accidents in the dementia population An approximately 3-fold increased risk of cerebrovascular adverse events has been seen in randomised placebo-controlled clinical trials in the dementia population with some atypical antipsychotics. The mechanism for this increase ...
Novel pharmacotherapeutic treatments for cocaine addiction R E V I E W
... was chosen at the same frequency as placebo and was not associated with positive subjective effects [25]. Recent clinical trials of modafinil in human subjects have highlighted either (1) the medication’s impact upon actual cocaine use or (2) its ability to mitigate symptoms associated with cocaine ...
... was chosen at the same frequency as placebo and was not associated with positive subjective effects [25]. Recent clinical trials of modafinil in human subjects have highlighted either (1) the medication’s impact upon actual cocaine use or (2) its ability to mitigate symptoms associated with cocaine ...
- White Rose Research Online
... The HTA Programme was set up in 1993. Its role is to ensure that high-quality research information on the costs, effectiveness and broader impact of health technologies is produced in the most efficient way for those who use, manage and provide care in the NHS. ‘Health technologies’ are broadly defi ...
... The HTA Programme was set up in 1993. Its role is to ensure that high-quality research information on the costs, effectiveness and broader impact of health technologies is produced in the most efficient way for those who use, manage and provide care in the NHS. ‘Health technologies’ are broadly defi ...
Stinging Nettle: the Bad, the Good, the Unknown
... studies suggesting efficacy were done with combination products that included stinging nettle but also several other potentially active ingredients.9,21,22 Toxicities in the studies have generally been mild. However, there does appear to be a possible basis for the potential use of these agents in B ...
... studies suggesting efficacy were done with combination products that included stinging nettle but also several other potentially active ingredients.9,21,22 Toxicities in the studies have generally been mild. However, there does appear to be a possible basis for the potential use of these agents in B ...
Placebo Effects in Guidelines, Practice, and Patient Choice:
... clinical management or treatment guidelines. The failure of providers to appreciate placebo effects represents a significant gap in care and is inconsistent with fully informed consent. Over the past few decades a variety of studies have demonstrated the effect of placebo in different clinical condi ...
... clinical management or treatment guidelines. The failure of providers to appreciate placebo effects represents a significant gap in care and is inconsistent with fully informed consent. Over the past few decades a variety of studies have demonstrated the effect of placebo in different clinical condi ...
Dry Eye Assessment and Management Manual of Procedures
... Exhibit 3-1 Returning or Destroying Expired or Damaged Run-in Supplement and Returned Supplement .............................................................................................................. 3-6 CHAPTER REFERENCES...................................................................... ...
... Exhibit 3-1 Returning or Destroying Expired or Damaged Run-in Supplement and Returned Supplement .............................................................................................................. 3-6 CHAPTER REFERENCES...................................................................... ...
AusPAR: Sevelamer hydrochloride
... 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. ...
the scientific value of non-clinical animal studies in drug development
... of animal studies, which is that it is a living model system that is being used to extrapolate results from. Animal model systems have high intrinsic variability, immutable differences within species and are also mechanistically not completely understood(17). Study design can influence all three fac ...
... of animal studies, which is that it is a living model system that is being used to extrapolate results from. Animal model systems have high intrinsic variability, immutable differences within species and are also mechanistically not completely understood(17). Study design can influence all three fac ...
Digoxin-specific antibody fragment F(ab) ovine
... current expectations for a standalone marketing authorisation application but this is a result of the emergency nature and the prevalence of the condition. The sponsor does not intend to conduct further clinical studies of DigiFab. ...
... current expectations for a standalone marketing authorisation application but this is a result of the emergency nature and the prevalence of the condition. The sponsor does not intend to conduct further clinical studies of DigiFab. ...