Public Assessment Report Scientific discussion Glatirameeracetaat
... The synthesis of glatiramer acetate results in the complex heterogeneous mixture of random polypeptide chains. In view of the heterogeneity of the substance and the limitations of release controls the MAH has fixed the drug substance manufacturing conditions rigorously in the dossier within narrow r ...
... The synthesis of glatiramer acetate results in the complex heterogeneous mixture of random polypeptide chains. In view of the heterogeneity of the substance and the limitations of release controls the MAH has fixed the drug substance manufacturing conditions rigorously in the dossier within narrow r ...
PDF - AIDS Research and Therapy
... competing with endogenous nucleotides to terminate HIV replication [17]. The d4T-TP also inhibits mitochondrial DNA polymerase gamma in a dose dependent manner in cells of various tissues, and effectively terminates mitochondrial replication with subsequent mitochondrial damage or depletion: the com ...
... competing with endogenous nucleotides to terminate HIV replication [17]. The d4T-TP also inhibits mitochondrial DNA polymerase gamma in a dose dependent manner in cells of various tissues, and effectively terminates mitochondrial replication with subsequent mitochondrial damage or depletion: the com ...
Outpatient Anticoagulation management
... (POC) finger stick INR testing and managing results using protocol • 50 POC tests/week • Pharmacist oversight and consultation ...
... (POC) finger stick INR testing and managing results using protocol • 50 POC tests/week • Pharmacist oversight and consultation ...
Prescribing information - Upsher
... Pregnancy Category B VANDAZOLE should be used during pregnancy only if clearly needed. There are no adequate and well-controlled studies in pregnant women. There are published data from case-control studies, cohort studies, and two meta-analyses that include more than 5000 pregnant women who used me ...
... Pregnancy Category B VANDAZOLE should be used during pregnancy only if clearly needed. There are no adequate and well-controlled studies in pregnant women. There are published data from case-control studies, cohort studies, and two meta-analyses that include more than 5000 pregnant women who used me ...
PDF (all abstracts) - Allergy, Asthma & Clinical Immunology
... Background: Capturing symptom data for large studies (≥60 participants) in ≤30 minutes is hard to achieve using manual data entry without substantial costs and resources. This challenge is highlighted if the data are needed to make real-time clinical decisions. The 140 participant capacity of the En ...
... Background: Capturing symptom data for large studies (≥60 participants) in ≤30 minutes is hard to achieve using manual data entry without substantial costs and resources. This challenge is highlighted if the data are needed to make real-time clinical decisions. The 140 participant capacity of the En ...
Terlipressin acetate - Therapeutic Goods Administration
... (approved under national registration procedures in both countries) and approval was pending in 19 countries, including 12 in Europe. No applications have been made for either product in Canada or the USA. The latest summaries of the worldwide marketing authorisation status will be included in the p ...
... (approved under national registration procedures in both countries) and approval was pending in 19 countries, including 12 in Europe. No applications have been made for either product in Canada or the USA. The latest summaries of the worldwide marketing authorisation status will be included in the p ...
Vemlidy - Gilead
... 5.1 Severe Exacerbation of Hepatitis B after Discontinuation of Treatment 5.2 Risk of Development of HIV-1 Resistance in Patients Coinfected with HBV and HIV-1 ...
... 5.1 Severe Exacerbation of Hepatitis B after Discontinuation of Treatment 5.2 Risk of Development of HIV-1 Resistance in Patients Coinfected with HBV and HIV-1 ...
Placebo interventions, placebo effects and clinical practice
... psychological, or psychophysiological effect, or that is used for its presumed specific effect, but is without specific activity for the condition being treated’. Shapiro & Morris further distinguish pure placebos, which are ‘treatments that are devoid of active, specific components’, and impure pla ...
... psychological, or psychophysiological effect, or that is used for its presumed specific effect, but is without specific activity for the condition being treated’. Shapiro & Morris further distinguish pure placebos, which are ‘treatments that are devoid of active, specific components’, and impure pla ...
Haloperidol and Slot Machine Gambling
... modest dose of haloperidol in non-Parkinsonian PG subjects may approximate the effects seen in PG subjects with Parkinson’s. That is, haloperidol may increase gamblinginduced DA release in otherwise healthy PG subjects. Frank and O’Reilly’s results suggest that this effect may also be observed in no ...
... modest dose of haloperidol in non-Parkinsonian PG subjects may approximate the effects seen in PG subjects with Parkinson’s. That is, haloperidol may increase gamblinginduced DA release in otherwise healthy PG subjects. Frank and O’Reilly’s results suggest that this effect may also be observed in no ...
Current treatment of oral candidiasis: A literature review
... Candidiasis or oral candidosis is one of the most common human opportunistic fungal infections of the oral cavity. This pathology has a wide variety of treatment which has been studied until these days. The present study offers a literature review on the treatment of oral candidiasis, with the purpo ...
... Candidiasis or oral candidosis is one of the most common human opportunistic fungal infections of the oral cavity. This pathology has a wide variety of treatment which has been studied until these days. The present study offers a literature review on the treatment of oral candidiasis, with the purpo ...
AusPAR: Lisdexamfetamine dimesilate
... First round benefit-risk assessment _______________________________________________ 52 Second round evaluation of clinical data submitted in response to questions _ 54 Second round benefit-risk assessment ____________________________________________ 58 ...
... First round benefit-risk assessment _______________________________________________ 52 Second round evaluation of clinical data submitted in response to questions _ 54 Second round benefit-risk assessment ____________________________________________ 58 ...
AusPAR: Lisdexamfetamine dimesilate
... 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. ...
Aristotle protocol - Leeds Virtual Pathology
... 12.2.7 SAE Processing at UCL CTC .................................................................................................................... 56 ...
... 12.2.7 SAE Processing at UCL CTC .................................................................................................................... 56 ...
PROBIOTIC SUPPLEMENTATION, KE
... showed evidence of allergy to the test drug and showed evidence of non-tolerability to the test drugs. In this case, the patient was terminated from the trial, but still included in the intention-to-treat analysis of the study. ...
... showed evidence of allergy to the test drug and showed evidence of non-tolerability to the test drugs. In this case, the patient was terminated from the trial, but still included in the intention-to-treat analysis of the study. ...
Extract from the Clinical Evaluation Report for tenofovir disoproxil
... This was a randomised, double-blind, placebo-controlled, Phase III study of the safety and efficacy of FTC/TDF for prophylaxis in seronegative MSM at high risk of acquiring HIV-1 infection. It was sponsored by the NIH and the National Institute of Allergy and Infectious Diseases, with co-funding fro ...
... This was a randomised, double-blind, placebo-controlled, Phase III study of the safety and efficacy of FTC/TDF for prophylaxis in seronegative MSM at high risk of acquiring HIV-1 infection. It was sponsored by the NIH and the National Institute of Allergy and Infectious Diseases, with co-funding fro ...
Goals of asthma treatment: how high should we go? EDITORIAL H.K. Reddel
... for clinical tools to identify noneosinophilic asthma or other non-steroid-responsive conditions, in order to avoid overtreatment. The GOAL study [2] will provide a valuable resource for prospective clinical identification of patients whose asthma remains "Uncontrolled" despite maximal doses of ICS ...
... for clinical tools to identify noneosinophilic asthma or other non-steroid-responsive conditions, in order to avoid overtreatment. The GOAL study [2] will provide a valuable resource for prospective clinical identification of patients whose asthma remains "Uncontrolled" despite maximal doses of ICS ...
Rivaroxaban for stroke prevention in atrial fibrillation
... The activated partial thromboplastin time (aPTT) and HepTest are also prolonged dosedependently; however, they are not recommended to assess the pharmacodynamic effect of rivaroxaban. There is no need for monitoring of coagulation parameters during treatment with rivaroxaban in clinical routine. Riv ...
... The activated partial thromboplastin time (aPTT) and HepTest are also prolonged dosedependently; however, they are not recommended to assess the pharmacodynamic effect of rivaroxaban. There is no need for monitoring of coagulation parameters during treatment with rivaroxaban in clinical routine. Riv ...
Marketing authorisation of new medicines in the EU: towards
... authorisation of new medicines. In Chapter 2.1 we study all new active substances discussed by the Committee for Medicinal Products for Human Use (CHMP) in 2009 and 2010 and evaluate to what extent deficits in the drug development plan, disappointing clinical outcome (both efficacy and safety) or do ...
... authorisation of new medicines. In Chapter 2.1 we study all new active substances discussed by the Committee for Medicinal Products for Human Use (CHMP) in 2009 and 2010 and evaluate to what extent deficits in the drug development plan, disappointing clinical outcome (both efficacy and safety) or do ...
EDEN protocol
... The principal analysis will be intent-to-treat, based upon randomization assignment. Trial progress will be evaluated by an independent Data and Safety Monitoring Board to determine if the study should stop for futility or efficacy. Interim analyses will be conducted after enrollment of approximatel ...
... The principal analysis will be intent-to-treat, based upon randomization assignment. Trial progress will be evaluated by an independent Data and Safety Monitoring Board to determine if the study should stop for futility or efficacy. Interim analyses will be conducted after enrollment of approximatel ...
Page 1 of 9 Clinical Policy: aflibercept (Eylea), ranibizumab
... Approval duration: Duration of request or 12 months (whichever is less); or 2. Refer to ERX.XXXX.## if diagnosis is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) III. Diagnoses/Indications for which coverage is NOT authorized: A. Non-FDA appro ...
... Approval duration: Duration of request or 12 months (whichever is less); or 2. Refer to ERX.XXXX.## if diagnosis is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) III. Diagnoses/Indications for which coverage is NOT authorized: A. Non-FDA appro ...
Tamiflu Prescribing Information
... Put an ancillary label on the bottle indicating “Shake Well Before Use.” Instruct the parent or caregiver that any unused suspension remaining in the bottle following completion of therapy must be discarded by either affixing an ancillary label to the bottle or adding a statement to the pharmacy lab ...
... Put an ancillary label on the bottle indicating “Shake Well Before Use.” Instruct the parent or caregiver that any unused suspension remaining in the bottle following completion of therapy must be discarded by either affixing an ancillary label to the bottle or adding a statement to the pharmacy lab ...
Efficacy, safety and tolerability of linezolid containing regimens in treating MDR-TB
... Due to the lack of available antibiotics to treat such difficult cases, linezolid is already used off-label to treat MDR-TB in several countries, despite the absence of randomised controlled clinical trials to assess efficacy, safety and tolerability and also large retrospective and prospective obse ...
... Due to the lack of available antibiotics to treat such difficult cases, linezolid is already used off-label to treat MDR-TB in several countries, despite the absence of randomised controlled clinical trials to assess efficacy, safety and tolerability and also large retrospective and prospective obse ...
Extract from the Clinical Evaluation Report for palonosetron
... Pharmacokinetics and Safety of Multiple Dose Administration of Palonosetron in Healthy Subjects.” Single-centre (US), double blind, randomised controlled trial including placebo, in a parallel group design involving healthy volunteers (n = 16) given single doses of palonosetron on 3 consecutive days ...
... Pharmacokinetics and Safety of Multiple Dose Administration of Palonosetron in Healthy Subjects.” Single-centre (US), double blind, randomised controlled trial including placebo, in a parallel group design involving healthy volunteers (n = 16) given single doses of palonosetron on 3 consecutive days ...
