Assessment Report For Sprycel
... The MAH did not conduct new non-clinical studies to support the use of dasatinib in the patient population covered by the new indication. This is acceptable as the initial marketing authorisation application included most of the studies required for a long term use in patients with long life expecta ...
... The MAH did not conduct new non-clinical studies to support the use of dasatinib in the patient population covered by the new indication. This is acceptable as the initial marketing authorisation application included most of the studies required for a long term use in patients with long life expecta ...
ENDOCYTE INC - Barchart.com
... The Company recognizes revenues from license and collaboration agreements when persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the fee is fixed or determinable, and there is reasonable assurance that the related amounts are collectible in accordanc ...
... The Company recognizes revenues from license and collaboration agreements when persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the fee is fixed or determinable, and there is reasonable assurance that the related amounts are collectible in accordanc ...
The Leading Source of Diabetes Business News
... — Stefano Del Prato, MD (University of Pisa, Pisa, Italy) at the European Association for the Study of Diabetes’ annual meeting in Lisbon, Portugal. On Combination Therapy for Type 2 Diabetes "Type 2 diabetes is a complex disease with multiple things happening at the same time. Yet we still use a st ...
... — Stefano Del Prato, MD (University of Pisa, Pisa, Italy) at the European Association for the Study of Diabetes’ annual meeting in Lisbon, Portugal. On Combination Therapy for Type 2 Diabetes "Type 2 diabetes is a complex disease with multiple things happening at the same time. Yet we still use a st ...
O F L O X A C IN O P H T H A L M IC S O L U T IO N U S P , 0 .3 %
... Pregnancy: Teratogenic Effects. Pregnancy Category C: Ofloxacin has been shown to have an embryocidal effect in rats and in rabbits when given in doses of 810 mg/kg/day (equivalent to 9000 times the maximum recommended daily ophthalmic dose) and 160 mg/kg/day (equivalent to 1800 times the maximum re ...
... Pregnancy: Teratogenic Effects. Pregnancy Category C: Ofloxacin has been shown to have an embryocidal effect in rats and in rabbits when given in doses of 810 mg/kg/day (equivalent to 9000 times the maximum recommended daily ophthalmic dose) and 160 mg/kg/day (equivalent to 1800 times the maximum re ...
Prior Authorization Drug Name Covered Uses Exclusion Criteria
... FOR MODERATE TO SEVERE CROHN'S DISEASE: TRIAL/FAILURE OF ONE OR MORE CONVENTIONAL THERAPIES FOR CROHN'S DISEASE SUCH AS CORTICOSTEROIDS, AZATHIOPRINE, MERCAPTOPURINE, METHOTREXATE, OR MESALAMINE. FOR ...
... FOR MODERATE TO SEVERE CROHN'S DISEASE: TRIAL/FAILURE OF ONE OR MORE CONVENTIONAL THERAPIES FOR CROHN'S DISEASE SUCH AS CORTICOSTEROIDS, AZATHIOPRINE, MERCAPTOPURINE, METHOTREXATE, OR MESALAMINE. FOR ...
Practice Parameters for Clinical Use of the Multiple Sleep
... usefulness of the MSLT, and a small but significant group of studies specifically address the operating characteristics of the MSLT as a diagnostic test. The Maintenance of Wakefulness Test (MWT), another laboratory-based objective measure of sleepiness/wakefulness, was not covered in the original p ...
... usefulness of the MSLT, and a small but significant group of studies specifically address the operating characteristics of the MSLT as a diagnostic test. The Maintenance of Wakefulness Test (MWT), another laboratory-based objective measure of sleepiness/wakefulness, was not covered in the original p ...
New trends in glaucoma risk, diagnosis & management Review Article
... tonometry (GAT) reading45. Although these devices do have some potential it remains to be seen how these fair with large scale clinical trials to validate their use. Other devices for continuous IOP monitoring are under development and the initial results appear encouraging. It remains to be seen ...
... tonometry (GAT) reading45. Although these devices do have some potential it remains to be seen how these fair with large scale clinical trials to validate their use. Other devices for continuous IOP monitoring are under development and the initial results appear encouraging. It remains to be seen ...
PrAVELOX® PrAVELOX® I.V.
... results of these tests; once results become available, appropriate therapy should be continued. Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent, but also on the possible emergence of bacte ...
... results of these tests; once results become available, appropriate therapy should be continued. Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent, but also on the possible emergence of bacte ...
Extract from the Clinical Evaluation Report for Dexamethasone
... © Commonwealth of Australia 2016 This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction fo ...
... © Commonwealth of Australia 2016 This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction fo ...
Form 10-Q
... acquiring operating assets and raising capital. The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, new technological innovations, protection of proprietary technology, dependence on key personnel, compliance with government regulations an ...
... acquiring operating assets and raising capital. The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, new technological innovations, protection of proprietary technology, dependence on key personnel, compliance with government regulations an ...
Slide 1
... Antitoxin is an effective treatment and will prevent further progression of symptoms but will not reverse established paralysis. •If administered early it may neutralise any circulating toxin •There are a number of antitoxin products available all of which have been derived from pooled animal immuno ...
... Antitoxin is an effective treatment and will prevent further progression of symptoms but will not reverse established paralysis. •If administered early it may neutralise any circulating toxin •There are a number of antitoxin products available all of which have been derived from pooled animal immuno ...
MetroCream
... Because of the minimal absorption of metronidazole, and consequently its insignificant plasma concentration after topical administration, the systemic adverse reactions reported with the oral form of the drug should not be expected with METROGEL, METROCREAM, or METROLOTION (metronidazole topical gel ...
... Because of the minimal absorption of metronidazole, and consequently its insignificant plasma concentration after topical administration, the systemic adverse reactions reported with the oral form of the drug should not be expected with METROGEL, METROCREAM, or METROLOTION (metronidazole topical gel ...
Opposite effects of MDMA
... pharmacodynamics and pharmacokinetics of MDMA. The study will use a randomized double-blind cross-over design with four experimental sessions. Duloxetine (120 mg) or placebo will be administered 16 h and 4 h before the administration of MDMA (125 mg) or placebo to 16 healthy volunteers. Subjective a ...
... pharmacodynamics and pharmacokinetics of MDMA. The study will use a randomized double-blind cross-over design with four experimental sessions. Duloxetine (120 mg) or placebo will be administered 16 h and 4 h before the administration of MDMA (125 mg) or placebo to 16 healthy volunteers. Subjective a ...
5.02 atazanavir + cobicistat
... - The assumed rates of market uptake for the proposed therapy were not justified. - Atazanavir/cobicistat FDC could substitute in clinical practice therapies other than atazanavir plus ritonavir. The submission explored the substitution of darunavir plus ritonavir, lopinavir/ritonavir FDC, and ataza ...
... - The assumed rates of market uptake for the proposed therapy were not justified. - Atazanavir/cobicistat FDC could substitute in clinical practice therapies other than atazanavir plus ritonavir. The submission explored the substitution of darunavir plus ritonavir, lopinavir/ritonavir FDC, and ataza ...
Minoxidil Topical Solution USP 2%
... higher doses were associated with more adverse events. Doses higher than 6 mg per day have not been studied. Patients experiencing persistent somnolence may benefit from administering half the daily dose twice daily. Maintenance Therapy There is no body of evidence available from controlled trials t ...
... higher doses were associated with more adverse events. Doses higher than 6 mg per day have not been studied. Patients experiencing persistent somnolence may benefit from administering half the daily dose twice daily. Maintenance Therapy There is no body of evidence available from controlled trials t ...
Current and Potential Drugs for Treatment of Obesity
... Obesity and hypertension have a number of features in common that may guide the future of drug development (1, 16). Before the introduction of chlorothiazide in 1958, hypertension had three major treatments: diet, drugs, and surgery. A low-salt diet was the dietary mainstay. If begun early enough, a ...
... Obesity and hypertension have a number of features in common that may guide the future of drug development (1, 16). Before the introduction of chlorothiazide in 1958, hypertension had three major treatments: diet, drugs, and surgery. A low-salt diet was the dietary mainstay. If begun early enough, a ...
AVELOX I.V. PRODUCT MONOGRAPH
... results of these tests; once results become available, appropriate therapy should be continued. Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent, but also on the possible emergence of bacte ...
... results of these tests; once results become available, appropriate therapy should be continued. Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent, but also on the possible emergence of bacte ...
Evaluation of efficacy and safety of Hyaluronic acid
... The study is a multicenter, randomized, open, positive and parallel controlled study, evaluating the efficacy and safety of Hyaluronic acid vaginal gel (Hyalofemme) for improvement of vaginal dryness. According to the protocol design, all subjects will be randomized into test group and control group ...
... The study is a multicenter, randomized, open, positive and parallel controlled study, evaluating the efficacy and safety of Hyaluronic acid vaginal gel (Hyalofemme) for improvement of vaginal dryness. According to the protocol design, all subjects will be randomized into test group and control group ...
Product Monograph
... PHARMACOLOGY, Special Populations and Conditions - Pediatrics). Therefore, until further data are available, use of linezolid in this age group is not recommended Geriatrics: Of the 2046 patients treated with ZYVOXAM in phase III comparator-controlled clinical trials, 589 (29%) were 65 years or olde ...
... PHARMACOLOGY, Special Populations and Conditions - Pediatrics). Therefore, until further data are available, use of linezolid in this age group is not recommended Geriatrics: Of the 2046 patients treated with ZYVOXAM in phase III comparator-controlled clinical trials, 589 (29%) were 65 years or olde ...
Sacubitril valsartan for treating symptomatic chronic heart failure
... The pivotal clinical evidence presented in the company's submission was taken from the PARADIGM-HF trial, which compared sacubitril valsartan with enalapril (an angiotensin-converting enzyme [ACE] inhibitor). The company also did a network meta-analysis to compare sacubitril valsartan with angiotens ...
... The pivotal clinical evidence presented in the company's submission was taken from the PARADIGM-HF trial, which compared sacubitril valsartan with enalapril (an angiotensin-converting enzyme [ACE] inhibitor). The company also did a network meta-analysis to compare sacubitril valsartan with angiotens ...
Oral Candidiasis
... • Erythematous candidiasis usually occurs on the dorsum of the tongue in persons who use corticosteroid inhalators due to asthma treatment • In individuals who have developed candidiasis secondary to the use of inhaled steroids, rinsing out the mouth with water after taking the steroid, and using a ...
... • Erythematous candidiasis usually occurs on the dorsum of the tongue in persons who use corticosteroid inhalators due to asthma treatment • In individuals who have developed candidiasis secondary to the use of inhaled steroids, rinsing out the mouth with water after taking the steroid, and using a ...
Introduction to SNOMED CT
... What is a SUBSET? • SNOMED CT is extensive – it is supporting a common vocabulary for all healthcare specialisms, and all healthcare professionals, as well as keeping up to date with current practice • A subset is ‘smaller set of SNOMED CT ‘ that meets a particular requirement • A SNOMED CT subset c ...
... What is a SUBSET? • SNOMED CT is extensive – it is supporting a common vocabulary for all healthcare specialisms, and all healthcare professionals, as well as keeping up to date with current practice • A subset is ‘smaller set of SNOMED CT ‘ that meets a particular requirement • A SNOMED CT subset c ...
DSU systematic review of adverse effects and persistence
... individual clinician’s assessment of causality to identify an adverse drug reaction. However, on average, only 58% of the questionnaires are returned, and only 52% provide clinically useful data. This is a potential source of bias as it is not known whether the patients whose doctors complete and r ...
... individual clinician’s assessment of causality to identify an adverse drug reaction. However, on average, only 58% of the questionnaires are returned, and only 52% provide clinically useful data. This is a potential source of bias as it is not known whether the patients whose doctors complete and r ...
Use of Buspirone for the Treatment of Anxiety: A Review
... relevant articles were retrieved for full-text review. Two potentially relevant reports were retrieved from grey literature and hand searching. Of the 12 potentially relevant reports, one contained an irrelevant population, two contained an irrelevant intervention, one was a duplicate and three were ...
... relevant articles were retrieved for full-text review. Two potentially relevant reports were retrieved from grey literature and hand searching. Of the 12 potentially relevant reports, one contained an irrelevant population, two contained an irrelevant intervention, one was a duplicate and three were ...
Clinical management of progressive myopia
... OrthoK requires a trial fitting set and a topographer is also essential to the fitting and follow-up process. Once the cornea has undergone reshaping, eyes are left with minimal refractive error, making it nearly impossible to detect mild myopic progression. Thus, in order to monitor progression, an ...
... OrthoK requires a trial fitting set and a topographer is also essential to the fitting and follow-up process. Once the cornea has undergone reshaping, eyes are left with minimal refractive error, making it nearly impossible to detect mild myopic progression. Thus, in order to monitor progression, an ...