AusPAR: Efmoroctocog alfa (rhu) - 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. ...
Drug therapy for ventricular tachyarrhythmias: How many
... Natural history studies (1-5) have reported high mortality rates among patients who have had sustained ventricular tachyarrhythmias without a reversible cause. However, the prognosis of such patients is improved with individualized antiarrhythmic therapy. A recent randomized trial (6) supported the ...
... Natural history studies (1-5) have reported high mortality rates among patients who have had sustained ventricular tachyarrhythmias without a reversible cause. However, the prognosis of such patients is improved with individualized antiarrhythmic therapy. A recent randomized trial (6) supported the ...
Xyrem®, sodium oxybate, dru093
... receiving placebo. Note that more than 80% of subjects were also taking modafinil during the trial, making it impossible to separate the effect of each medication. [1-5] ...
... receiving placebo. Note that more than 80% of subjects were also taking modafinil during the trial, making it impossible to separate the effect of each medication. [1-5] ...
Nanobodies
... ! Surface plasmon resonance as powerful tool to perform isotyping, to pin point reactivity by testing on different building blocks, is used as quality control of ADA results www.ablynx.com ...
... ! Surface plasmon resonance as powerful tool to perform isotyping, to pin point reactivity by testing on different building blocks, is used as quality control of ADA results www.ablynx.com ...
united states securities and exchange commission - corporate
... acute myeloid leukemia (AML). The VALOR trial employs an adaptive trial design that permits a one-time increase in sample size at the interim analysis by its Data and Safety Monitoring Board (DSMB). At the interim analysis, expected in the third quarter of 2012, the DSMB will examine pre-specified e ...
... acute myeloid leukemia (AML). The VALOR trial employs an adaptive trial design that permits a one-time increase in sample size at the interim analysis by its Data and Safety Monitoring Board (DSMB). At the interim analysis, expected in the third quarter of 2012, the DSMB will examine pre-specified e ...
Dictionary of Pharmaceutical Medicine
... consequence, some important documents are listed in the back matter of this book. It was after all these deliberations that the idea of producing this particular type of short dictionary in its present form was born. As is the problem with almost all dictionaries, information given therein must be s ...
... consequence, some important documents are listed in the back matter of this book. It was after all these deliberations that the idea of producing this particular type of short dictionary in its present form was born. As is the problem with almost all dictionaries, information given therein must be s ...
Major Clinical Trial - University of Kelaniya
... monitoring board assessed the progress of the trial at intervals by performing safety reviews and predefined interim analyses. An independent academic research organization (Singapore Clinical Research Institute) was responsible for managing study conduct, monitoring data, and performing statistical ...
... monitoring board assessed the progress of the trial at intervals by performing safety reviews and predefined interim analyses. An independent academic research organization (Singapore Clinical Research Institute) was responsible for managing study conduct, monitoring data, and performing statistical ...
pan-Canadian Oncology Drug Review Initial Clinical Guidance
... policymakers make well-informed decisions and thereby improve the quality of health care services. While patients and others may use this report, they are made available for informational and educational purposes only. This report should not be used as a substitute for the application of clinical ju ...
... policymakers make well-informed decisions and thereby improve the quality of health care services. While patients and others may use this report, they are made available for informational and educational purposes only. This report should not be used as a substitute for the application of clinical ju ...
Attachment 1. Product Information - 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. ...
Safety of formoterol in asthma clinical trials: an update Malcolm R. Sears
... Food and Drug Administration (FDA) [1]. Concerns initially arose through the results of a clinical trial conducted in the UK with salmeterol versus salbutamol [2] and were heightened by results of a large study in the USA of adding salmeterol or placebo to current therapy [3], in which increased ris ...
... Food and Drug Administration (FDA) [1]. Concerns initially arose through the results of a clinical trial conducted in the UK with salmeterol versus salbutamol [2] and were heightened by results of a large study in the USA of adding salmeterol or placebo to current therapy [3], in which increased ris ...
Protocol Title - NIHR Journals Library Admin. | User Login
... chimeric monoclonal antibody directed against the CD20 antigen expressed by B cells, has been approved by the US Food and Drug Administration and by the European Medicines Agency in Europe for the treatment of patients with RA who have had an inadequate response (ir) or were intolerant to tumour nec ...
... chimeric monoclonal antibody directed against the CD20 antigen expressed by B cells, has been approved by the US Food and Drug Administration and by the European Medicines Agency in Europe for the treatment of patients with RA who have had an inadequate response (ir) or were intolerant to tumour nec ...
Tuberculous and brucellosis meningitis differential diagnosis
... tuberculous meningitis (TBM) [1,4]. Although the diagnosis of BME is relatively easy [5], the diagnosis of TBM is challenging as culture is very slow and non-culture diagnostic methods lack sensitivity [6]. For this reason, two prediction systems, Thwaites and Lancet, have been developed in the rapi ...
... tuberculous meningitis (TBM) [1,4]. Although the diagnosis of BME is relatively easy [5], the diagnosis of TBM is challenging as culture is very slow and non-culture diagnostic methods lack sensitivity [6]. For this reason, two prediction systems, Thwaites and Lancet, have been developed in the rapi ...
Knowledge
... Pharmacodynamics – studies what effect drugs have on the body and how it happens. This includes not just the cellular and molecular aspects, but also the relevant clinical laboratory or instrumental parameters. Correct prescribing – includes using the right medication, at the right dose, with the r ...
... Pharmacodynamics – studies what effect drugs have on the body and how it happens. This includes not just the cellular and molecular aspects, but also the relevant clinical laboratory or instrumental parameters. Correct prescribing – includes using the right medication, at the right dose, with the r ...
Duloxetine and Other Antidepressants in the
... had a ≥50% reduction in the Brief Pain Inventory average pain severity score. Compared with placebo, duloxetine 60 mg QD or duloxetine 60 mg BID resulted in significantly greater improvement in the remaining Brief Pain Inventory pain severity and interference scores, and other secondary outcomes incl ...
... had a ≥50% reduction in the Brief Pain Inventory average pain severity score. Compared with placebo, duloxetine 60 mg QD or duloxetine 60 mg BID resulted in significantly greater improvement in the remaining Brief Pain Inventory pain severity and interference scores, and other secondary outcomes incl ...
Review Process - EMBO Molecular Medicine
... The reviewers made some very useful suggestions and we hope they will agree that our attempts to address their concerns have further strengthened our studies. We apologize for the delayed response to their constructive comments. Due to staff turnover, we had to train a new team to carry out experime ...
... The reviewers made some very useful suggestions and we hope they will agree that our attempts to address their concerns have further strengthened our studies. We apologize for the delayed response to their constructive comments. Due to staff turnover, we had to train a new team to carry out experime ...
FDA
... veterinary drugs, vaccines and other biological products, medical devices, most of our nations food supply, all cosmetics, dietary supplements, and products that emit radiation, and by regulating the manufacture, marketing, and distribution of tobacco products • FDA is also responsible for advancing ...
... veterinary drugs, vaccines and other biological products, medical devices, most of our nations food supply, all cosmetics, dietary supplements, and products that emit radiation, and by regulating the manufacture, marketing, and distribution of tobacco products • FDA is also responsible for advancing ...
Jumbe N, Yao B, Rovetti R, Rossi G, Heatherington A. (2002)
... feasibility of a fixed 200- J..tg dose of darbepoetin alfa (Aranesp) administered every 2 weeks in chemotherapy-induced anemia. A pharmacokineticlpharmacodynamic model was developed using clinical data from 547 cancer patients who received darbepoetin alfa at various doses and schedules. Monte Carlo ...
... feasibility of a fixed 200- J..tg dose of darbepoetin alfa (Aranesp) administered every 2 weeks in chemotherapy-induced anemia. A pharmacokineticlpharmacodynamic model was developed using clinical data from 547 cancer patients who received darbepoetin alfa at various doses and schedules. Monte Carlo ...
Heparin, low-molecular–weight heparins, and heparin - hem
... clinicians, it is now well recognized that heparin has multiple sites of actions and can be used for many clinical indications. It is heparin that yielded the LMWHs, synthetic oligosaccharides such as the chemically synthesized pentasaccharides, chemically modified heparins, and biotechnologically d ...
... clinicians, it is now well recognized that heparin has multiple sites of actions and can be used for many clinical indications. It is heparin that yielded the LMWHs, synthetic oligosaccharides such as the chemically synthesized pentasaccharides, chemically modified heparins, and biotechnologically d ...
Extract from the Clinical Evaluation
... fingolimod and cladribine. There is also increasing evidence suggesting that early immune modulation is more effective than delayed treatment (Gold et al, 2010). In particular, for most of the established, first-line MS treatments, published studies have already shown that early treatment of CIS del ...
... fingolimod and cladribine. There is also increasing evidence suggesting that early immune modulation is more effective than delayed treatment (Gold et al, 2010). In particular, for most of the established, first-line MS treatments, published studies have already shown that early treatment of CIS del ...
Low-Dose Otelixizumab Anti-CD3 Monoclonal Antibody DEFEND
... period, to reduce the possibility of unblinding. An unblinded independent medical monitor did have access to such laboratory data. Although the unblinded independent medical monitor did not know subject treatment group assignments, that person could potentially become unblinded by reviewing data. Du ...
... period, to reduce the possibility of unblinding. An unblinded independent medical monitor did have access to such laboratory data. Although the unblinded independent medical monitor did not know subject treatment group assignments, that person could potentially become unblinded by reviewing data. Du ...
Strategies for Reduction in Duration of Antibiotic Use in Hospitalized
... tradition and expert opinion rather than on RCTs. The recommended duration of antimicrobial therapy in IDSA guidelines is 7–21 days, depending on the organism (Table 2) [31]. However, shorter courses have been studied in some settings. One or 2 intramuscular injections of long-acting chloramphenicol ...
... tradition and expert opinion rather than on RCTs. The recommended duration of antimicrobial therapy in IDSA guidelines is 7–21 days, depending on the organism (Table 2) [31]. However, shorter courses have been studied in some settings. One or 2 intramuscular injections of long-acting chloramphenicol ...
Potential Herb-Drug Interactions for Commonly
... It is recommended that St John’s wort is contraindicated in patients taking cancer chemotherapeutic drugs. In the case of gliclazide, because the trial found little effect on a clinically-relevant outcome, the potential interaction is considered low risk and a caution is recommended: the patient ...
... It is recommended that St John’s wort is contraindicated in patients taking cancer chemotherapeutic drugs. In the case of gliclazide, because the trial found little effect on a clinically-relevant outcome, the potential interaction is considered low risk and a caution is recommended: the patient ...
Efficacy of Diosmectite (Smecta)® in the Treatment of Acute Watery
... parameters and safety in adults with acute watery diarrhoea. 2.6. Primary Outcome Measure. Time to recovery was defined as the time (hours) from first study drug intake (H0) to diarrhoea recovery. Recovery was defined as the first formed or hard stool followed by a nonwatery stool. Time to recovery ...
... parameters and safety in adults with acute watery diarrhoea. 2.6. Primary Outcome Measure. Time to recovery was defined as the time (hours) from first study drug intake (H0) to diarrhoea recovery. Recovery was defined as the first formed or hard stool followed by a nonwatery stool. Time to recovery ...
FF Principal Investigator/Program Director (Last, first, middle): Orban
... The study is a 2-arm, multicenter, randomized, placebo controlled masked clinical trial. All subjects will receive close monitoring for development of type 1 diabetes. Subjects will receive teplizumab + close monitoring for development of type 1 diabetes or placebo + close monitoring for development ...
... The study is a 2-arm, multicenter, randomized, placebo controlled masked clinical trial. All subjects will receive close monitoring for development of type 1 diabetes. Subjects will receive teplizumab + close monitoring for development of type 1 diabetes or placebo + close monitoring for development ...