Atrial Fibrillation
... Murgatroyd, F.D., Krahn, A.D., Klein, G.J., Yee, R.K, & Skanes, A..C(2001). Atrial Arrhythmias. In Murgatroyd, F.D., Krahn, A.D., Klein, G.J., Yee, R.K, & Skanes, Handbook of Cardiac Electrophysiology (55-71). London: ReMEDICA ...
... Murgatroyd, F.D., Krahn, A.D., Klein, G.J., Yee, R.K, & Skanes, A..C(2001). Atrial Arrhythmias. In Murgatroyd, F.D., Krahn, A.D., Klein, G.J., Yee, R.K, & Skanes, Handbook of Cardiac Electrophysiology (55-71). London: ReMEDICA ...
rch - Therapeutic Goods Administration
... the risk of cardiovascular events and serum lipid reduction is advocated in international guidelines for managing cardiovascular risk. Homozygous familial hypercholesterolaemia (HoFH) is a rare disorder occurring in approximately 1:1 million births, whereas heterozygous familial hypercholesterolaemi ...
... the risk of cardiovascular events and serum lipid reduction is advocated in international guidelines for managing cardiovascular risk. Homozygous familial hypercholesterolaemia (HoFH) is a rare disorder occurring in approximately 1:1 million births, whereas heterozygous familial hypercholesterolaemi ...
Adverse_Events_White_Paper
... The development of standard TFLs and associated analyses will lead to improved standardization of AE data from collection through data display and analysis. The development of standard TFLs will also lead to improved and harmonized product lifecycle management across therapeutic areas by ensuring th ...
... The development of standard TFLs and associated analyses will lead to improved standardization of AE data from collection through data display and analysis. The development of standard TFLs will also lead to improved and harmonized product lifecycle management across therapeutic areas by ensuring th ...
Lucentis : EPAR - Scientific Discussion
... These studies have shown that AMD is rare before 55 years of age - being more common in persons 75 years of age or older, and that it is less common in blacks than in whites. AMD is classified into two different types: the non-exudative (or dry) form and the exudative (wet or neovascular) form. The ...
... These studies have shown that AMD is rare before 55 years of age - being more common in persons 75 years of age or older, and that it is less common in blacks than in whites. AMD is classified into two different types: the non-exudative (or dry) form and the exudative (wet or neovascular) form. The ...
Stroke - Multidisciplinary Association for Psychedelic Studies
... study of the therapeutic use of MDMA in any patient population has yet to be conducted, despite considerable efforts to obtain permission for such studies. Samuel Widmer, MD, Peter Gasser, MD, and other members of the Swiss Medical Society for Psycholytic Therapy received permission from the Swiss M ...
... study of the therapeutic use of MDMA in any patient population has yet to be conducted, despite considerable efforts to obtain permission for such studies. Samuel Widmer, MD, Peter Gasser, MD, and other members of the Swiss Medical Society for Psycholytic Therapy received permission from the Swiss M ...
FLOVENT DISKUS (fluticasone propionate inhalation
... systemically available inhaled corticosteroids. After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic-pituitary-adrenal (HPA) function. Patients who have been previously maintained on 20 mg or more of prednisone (or its equivalent) may be most s ...
... systemically available inhaled corticosteroids. After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic-pituitary-adrenal (HPA) function. Patients who have been previously maintained on 20 mg or more of prednisone (or its equivalent) may be most s ...
triumeq - GSK Source
... when other diagnoses are possible (e.g., acute onset respiratory diseases such as pneumonia, bronchitis, pharyngitis, or influenza; gastroenteritis; or reactions to other medications). Clinical status, including liver chemistries, should be monitored and appropriate therapy initiated. ...
... when other diagnoses are possible (e.g., acute onset respiratory diseases such as pneumonia, bronchitis, pharyngitis, or influenza; gastroenteritis; or reactions to other medications). Clinical status, including liver chemistries, should be monitored and appropriate therapy initiated. ...
Mecamylamine (a nicotine antagonist) for smoking cessation
... treated for four weeks prior to cessation with one of four treatments: 1. Nicotine patch plus mecamylamine capsules 2. Nicotine alone 3. Mecamylamine alone 4. No active drug. All four groups received combination treatment with nicotine and mecamylamine after the scheduled quit date. The abstinence r ...
... treated for four weeks prior to cessation with one of four treatments: 1. Nicotine patch plus mecamylamine capsules 2. Nicotine alone 3. Mecamylamine alone 4. No active drug. All four groups received combination treatment with nicotine and mecamylamine after the scheduled quit date. The abstinence r ...
RNS System Clinical Summary
... epilepsy surgery. Implantation of the RNS System should be performed only by qualified neurosurgeons at centers capable of providing comprehensive epilepsy care, i.e. “Comprehensive Epilepsy Centers”. These centers should have the expertise to provide diagnostic services that include video-EEG monit ...
... epilepsy surgery. Implantation of the RNS System should be performed only by qualified neurosurgeons at centers capable of providing comprehensive epilepsy care, i.e. “Comprehensive Epilepsy Centers”. These centers should have the expertise to provide diagnostic services that include video-EEG monit ...
PSAPVII_Book4_ Pediatrics.indb
... about the risks, and benefits of using a drug in a child when no information on dosing, efficacy, or safety in the pediatric population was available. That lack of information was reflected by the absence of pediatric dosing information in U.S. Food and Drug Administration (FDA)-approved labeling, w ...
... about the risks, and benefits of using a drug in a child when no information on dosing, efficacy, or safety in the pediatric population was available. That lack of information was reflected by the absence of pediatric dosing information in U.S. Food and Drug Administration (FDA)-approved labeling, w ...
SERIES ‘‘PULMONARY HYPERTENSION: BASIC CONCEPTS FOR PRACTICAL MANAGEMENT’’
... Most of the PAH drug studies in which a significant change in 6MWD has been demonstrated have enrolled patients with advanced pulmonary vascular disease, in whom the 6MWD is at least moderately reduced and pulmonary vascular resistance is already severely elevated. In future studies of PAH treatment ...
... Most of the PAH drug studies in which a significant change in 6MWD has been demonstrated have enrolled patients with advanced pulmonary vascular disease, in whom the 6MWD is at least moderately reduced and pulmonary vascular resistance is already severely elevated. In future studies of PAH treatment ...
The World Federation of Societies of Biological Psychiatry
... of drug trials, referring to mania with some depressed features which are either not pronounced enough or insufficiently lasting enough to fulfil the criteria for a major depressive episode. Tables I and II summarize DSM-IV diagnostic criteria for mania and mixed episodes. However, the complexity of ...
... of drug trials, referring to mania with some depressed features which are either not pronounced enough or insufficiently lasting enough to fulfil the criteria for a major depressive episode. Tables I and II summarize DSM-IV diagnostic criteria for mania and mixed episodes. However, the complexity of ...
The World Federation of Societies of Biological Psychiatry (WFSBP)
... of drug trials, referring to mania with some depressed features which are either not pronounced enough or insufficiently lasting enough to fulfil the criteria for a major depressive episode. Tables I and II summarize DSM-IV diagnostic criteria for mania and mixed episodes. However, the complexity of ...
... of drug trials, referring to mania with some depressed features which are either not pronounced enough or insufficiently lasting enough to fulfil the criteria for a major depressive episode. Tables I and II summarize DSM-IV diagnostic criteria for mania and mixed episodes. However, the complexity of ...
Investigative guidelines for alopecia areata
... agents, applied topically or injected intralesionally, are to be used on all alopecic areas rather than just those on one side of the scalp. This study design ...
... agents, applied topically or injected intralesionally, are to be used on all alopecic areas rather than just those on one side of the scalp. This study design ...
zidovudine and lamivudine - WHO archives
... Medicines. The drugs are generally used together to form a ‘nucleoside core’ to which other drugs are added. The drugs are being proposed for listing jointly because they are the most widely investigated, and most commonly used, dual nucleoside regimen in contemporary multi-drug antiretroviral regim ...
... Medicines. The drugs are generally used together to form a ‘nucleoside core’ to which other drugs are added. The drugs are being proposed for listing jointly because they are the most widely investigated, and most commonly used, dual nucleoside regimen in contemporary multi-drug antiretroviral regim ...
US Product Labeling @std Template for PLR
... not carry the HLA-B*5701 allele [see Warnings and Precautions (5.1)]. ZIAGEN is contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA-B*5701-positive patients [see Contraindications (4), Warnings and Precautions (5.1)]. All patients should be screened for the HLA- ...
... not carry the HLA-B*5701 allele [see Warnings and Precautions (5.1)]. ZIAGEN is contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA-B*5701-positive patients [see Contraindications (4), Warnings and Precautions (5.1)]. All patients should be screened for the HLA- ...
HIGHLIGHTS OF PRESCRIBING INFORMATION
... Studies have not been performed with DUAC Gel or benzoyl peroxide to evaluate the effect on fertility. Fertility studies in rats treated orally with up to 300 mg/kg/day of clindamycin (approximately 120 times the amount of clindamycin in the highest recommended adult human dose of 2.5 g DUAC Gel, ba ...
... Studies have not been performed with DUAC Gel or benzoyl peroxide to evaluate the effect on fertility. Fertility studies in rats treated orally with up to 300 mg/kg/day of clindamycin (approximately 120 times the amount of clindamycin in the highest recommended adult human dose of 2.5 g DUAC Gel, ba ...
Advances in Aromatase Inhibition
... of the above two trials showed that approximately one-third of patients who were treated with either anastrozole (1 mg or 10 mg, once daily) or megestrol acetate (160 mg daily) derived clinical benefit from their treatment (58). There were no statistically significant differences among the three tre ...
... of the above two trials showed that approximately one-third of patients who were treated with either anastrozole (1 mg or 10 mg, once daily) or megestrol acetate (160 mg daily) derived clinical benefit from their treatment (58). There were no statistically significant differences among the three tre ...
Guidelines on Similar Biologic: Regulatory Requirements for
... marketing Similar Biologics in India. So far, these Similar Biologics were approved by RCGM and CDSCO using an abbreviated version of the pathway applicable to new drugs on a case by case basis. Since there are several such products under development in India, both regulatory agencies considered the ...
... marketing Similar Biologics in India. So far, these Similar Biologics were approved by RCGM and CDSCO using an abbreviated version of the pathway applicable to new drugs on a case by case basis. Since there are several such products under development in India, both regulatory agencies considered the ...
revised clinical study protocol 1
... pharmacokinetic (PK) data to progress the compound whilst exposing as few patients as possible to AZD9773. The study will consist of 2 successive cohorts, with a total of 20 patients planned (10 patients per cohort) from approximately 10 Japanese sites. For each cohort, initially 10 patients will be ...
... pharmacokinetic (PK) data to progress the compound whilst exposing as few patients as possible to AZD9773. The study will consist of 2 successive cohorts, with a total of 20 patients planned (10 patients per cohort) from approximately 10 Japanese sites. For each cohort, initially 10 patients will be ...
CPR Review for Healthcare Providers:
... Topic and Lesson Structure (Absorb, Do, Connect) ..................................................................... 9 ...
... Topic and Lesson Structure (Absorb, Do, Connect) ..................................................................... 9 ...
Systematic review and cost-effectiveness evaluation of `pill-in
... Second, the HTA programme provides grants for clinical trials for researchers who identify research questions. These are assessed for importance to patients and the NHS, and scientific rigour. Third, through its Technology Assessment Report (TAR) call-off contract, the HTA programme commissions besp ...
... Second, the HTA programme provides grants for clinical trials for researchers who identify research questions. These are assessed for importance to patients and the NHS, and scientific rigour. Third, through its Technology Assessment Report (TAR) call-off contract, the HTA programme commissions besp ...
Running head: FACTORS THAT INFLUENCE
... prophylactic therapy, etc. When medications are used properly, the patient’s health will be optimized. Due to the great amount of advancements made in pharmaceutical research and production, clinicians now have a vast amount of options on what drugs they use, how to use them and when they use them. ...
... prophylactic therapy, etc. When medications are used properly, the patient’s health will be optimized. Due to the great amount of advancements made in pharmaceutical research and production, clinicians now have a vast amount of options on what drugs they use, how to use them and when they use them. ...
![[FDA Approved Labeling for Zoloft® for the Treatment of Social... Attachment to FDA Approval Letter for NDA 19-839/S-045]](http://s1.studyres.com/store/data/007848075_2-b414df0c18881254f6b13983cc9df393-300x300.png)
[FDA Approved Labeling for Zoloft® for the Treatment of Social... Attachment to FDA Approval Letter for NDA 19-839/S-045]
... decrease in the YBOCS score of ≥ 25% compared to baseline and a CGI-I of 1 (very much improved), 2 (much improved) or 3 (minimally improved). Relapse during the double-blind phase was defined as the following conditions being met (on three consecutive visits for 1 and 2, and for visit 3 for conditio ...
... decrease in the YBOCS score of ≥ 25% compared to baseline and a CGI-I of 1 (very much improved), 2 (much improved) or 3 (minimally improved). Relapse during the double-blind phase was defined as the following conditions being met (on three consecutive visits for 1 and 2, and for visit 3 for conditio ...
X - QIBA Wiki
... specific windows about each time point that would constitute an appropriate variance for that specific clinical trial ...
... specific windows about each time point that would constitute an appropriate variance for that specific clinical trial ...