Guidelines on evaluation of monoclonal antibodies as similar
... also the erythrocyte sedimentation rate (ESR) or C reactive protein (CRP) levels indicating how active the rheumatoid arthritis is at this time, and a patient’s global assessment of health. Equivalence margin: A pre-specified value in the equivalence trials, which is the largest difference that can ...
... also the erythrocyte sedimentation rate (ESR) or C reactive protein (CRP) levels indicating how active the rheumatoid arthritis is at this time, and a patient’s global assessment of health. Equivalence margin: A pre-specified value in the equivalence trials, which is the largest difference that can ...
Adalimumab Humira® – Abbott Laboratories Limited
... Review Report (a systematic review of the clinical evidence) and the CDR Pharmacoeconomic Review Report (a critique of the pharmacoeconomic evaluation submitted by the manufacturer). These reports were prepared by the CDR to support the Canadian Expert Drug Advisory Committee (CEDAC) in making a for ...
... Review Report (a systematic review of the clinical evidence) and the CDR Pharmacoeconomic Review Report (a critique of the pharmacoeconomic evaluation submitted by the manufacturer). These reports were prepared by the CDR to support the Canadian Expert Drug Advisory Committee (CEDAC) in making a for ...
AAPM Report No 121
... medical products are used in a manner not specified in the labeling, it is commonly referred to as off-label use. The practice of medicine allows for this off-label use to treat individual patients, but the ethical and legal implications for such unapproved use can be confusing. Although the respons ...
... medical products are used in a manner not specified in the labeling, it is commonly referred to as off-label use. The practice of medicine allows for this off-label use to treat individual patients, but the ethical and legal implications for such unapproved use can be confusing. Although the respons ...
Full Text - Iranian Journal of Dermatology
... the plant derived medicines are used in modern medicine, in a way that their modern application directly correlates with their traditional use as herbal medicines by native cultures 1. WHO estimates that 65–80% of the world’s population uses traditional medicines as their primary form of health care ...
... the plant derived medicines are used in modern medicine, in a way that their modern application directly correlates with their traditional use as herbal medicines by native cultures 1. WHO estimates that 65–80% of the world’s population uses traditional medicines as their primary form of health care ...
Oral NSAIDs – An Update
... Products for Human Use (CHMP) of the European Medicines Agency (EMA) reviewed NSAIDs in relation to possible CV risks, GI side effects and serious skin reactions. At this time, they concluded that the overall benefit-risk balance of these medicines was positive, but a small increased CV risk could n ...
... Products for Human Use (CHMP) of the European Medicines Agency (EMA) reviewed NSAIDs in relation to possible CV risks, GI side effects and serious skin reactions. At this time, they concluded that the overall benefit-risk balance of these medicines was positive, but a small increased CV risk could n ...
a high performance liquid chromatographic assay of rifampin in
... hours after administration. It is 75% bound to plasma proteins (Ref) and it is metabolized in the liver to an active metabolite, deacetylrifampin and undergoes enterohepatic recycling (Ref). Preliminary data suggest that patients infected with mycobacteria have altered pharmacokinetic profiles for r ...
... hours after administration. It is 75% bound to plasma proteins (Ref) and it is metabolized in the liver to an active metabolite, deacetylrifampin and undergoes enterohepatic recycling (Ref). Preliminary data suggest that patients infected with mycobacteria have altered pharmacokinetic profiles for r ...
Patient compliance in a clinical trial with inhaled budesonide in
... treatment significantly affected the compliance in this group of children with mild asthma. Younger children had a better compliance, possibly due to stronger parental supervision with extra motivation and help. In the present study, the children were repeatedly encouraged and reminded to take their ...
... treatment significantly affected the compliance in this group of children with mild asthma. Younger children had a better compliance, possibly due to stronger parental supervision with extra motivation and help. In the present study, the children were repeatedly encouraged and reminded to take their ...
ADULTERATION OF HERBAL MEDICINES AND DIETARY SUPPLEMENTS WITH UNDECLARED
... The popularity of using herbal medicines, nutraceuticals or food supplement is increasing all over the world due to the obligatory side-effects, in some cases tremendous side-effects, of synthetic medicines. The vital concept in favour of the huge consumption of herbal medicine is that the marketers ...
... The popularity of using herbal medicines, nutraceuticals or food supplement is increasing all over the world due to the obligatory side-effects, in some cases tremendous side-effects, of synthetic medicines. The vital concept in favour of the huge consumption of herbal medicine is that the marketers ...
the agents influencing functions of the effectory organs and systems
... glycoside. In 10-15 min, his condition improved and maximal effect - was in 1-1,5 hours, after that the action gradually decreased. What drug has been injected? A. * Strophanthin В. Digoxin C. Celanidum D. Digltoxin E. Adonisidum 2. A patient had been suffering from heart insufficiency was treated w ...
... glycoside. In 10-15 min, his condition improved and maximal effect - was in 1-1,5 hours, after that the action gradually decreased. What drug has been injected? A. * Strophanthin В. Digoxin C. Celanidum D. Digltoxin E. Adonisidum 2. A patient had been suffering from heart insufficiency was treated w ...
View Full Prescribing Information - AcipHex Sprinkle (rabeprazole
... Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines [see Dosage and Administration (2), Adverse Reactions (6.2)]. ACIPHEX Sprinkle is indicated for short-term treatment of up to 12 weeks. Treatment for longer than 12 weeks is not recomm ...
... Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines [see Dosage and Administration (2), Adverse Reactions (6.2)]. ACIPHEX Sprinkle is indicated for short-term treatment of up to 12 weeks. Treatment for longer than 12 weeks is not recomm ...
leucovorin - Cancer Care Ontario
... Refer to monitoring parameters in related regimen monographs. Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph. back to top ...
... Refer to monitoring parameters in related regimen monographs. Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph. back to top ...
DATA SHEET IOPIDINE (apraclonidine hydrochloride) Eye Drops
... The IOP-lowering efficacy of IOPIDINE Eye Drops 0.5% diminishes over time in some patients. This loss of effect, or tachyphylaxis, appears to be an individual occurrence with a variable time of onset and should be closely monitored. The benefit for most patients is less than one month. DOSAGE AND AD ...
... The IOP-lowering efficacy of IOPIDINE Eye Drops 0.5% diminishes over time in some patients. This loss of effect, or tachyphylaxis, appears to be an individual occurrence with a variable time of onset and should be closely monitored. The benefit for most patients is less than one month. DOSAGE AND AD ...
REVERSE PHASE HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE
... Objective: To develop a simple, precise, accurate, linear and rapid Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method for the simultaneous quantitative estimation of Troxerutin 500 mg and Calcium dobesilate 500 mg in tablets as per ICH guidelines. Methods: The method uses revers ...
... Objective: To develop a simple, precise, accurate, linear and rapid Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method for the simultaneous quantitative estimation of Troxerutin 500 mg and Calcium dobesilate 500 mg in tablets as per ICH guidelines. Methods: The method uses revers ...
Water Soluble Polymers for Pharmaceutical Applications
... from the body because it is not recognized as the foreign body. Therefore, the majority of conjugated drugs as well as liposomal and micellar formulations on the market or in advanced clinical trials are PEG-containing products [8]. Most of the polymer-based stealth drug-delivery systems that have r ...
... from the body because it is not recognized as the foreign body. Therefore, the majority of conjugated drugs as well as liposomal and micellar formulations on the market or in advanced clinical trials are PEG-containing products [8]. Most of the polymer-based stealth drug-delivery systems that have r ...
DEVELOPMENT AND VALIDATION OF NEWER ANALYTICAL METHODS FOR THE ESTIMATION
... 5 ml of standard stock solution of Deferasirox was pipetted out in to 100 ml standard flask. To this added 20 ml of alkaline borate buffer, 5 ml of (0.1%) Gibb’s reagent were added and kept for 15 minutes. The volume was made up to the mark with distilled water to get concentration of 10 µg/ ml. The ...
... 5 ml of standard stock solution of Deferasirox was pipetted out in to 100 ml standard flask. To this added 20 ml of alkaline borate buffer, 5 ml of (0.1%) Gibb’s reagent were added and kept for 15 minutes. The volume was made up to the mark with distilled water to get concentration of 10 µg/ ml. The ...
Pobierz plik
... good anti-TB activities of YH-8 had no cross-resistance with the first-line anti-tuberculosis drugs with the minimum inhibitory concentration (MIC) value of 0.125 µg/mL against M. tuberculosis including MDR-TB (24). The anti-TB activity of YH-8 is significantly higher than those of the reported PknB ...
... good anti-TB activities of YH-8 had no cross-resistance with the first-line anti-tuberculosis drugs with the minimum inhibitory concentration (MIC) value of 0.125 µg/mL against M. tuberculosis including MDR-TB (24). The anti-TB activity of YH-8 is significantly higher than those of the reported PknB ...
ASSESSMENT OF PHARMACEUTICAL QUALITY CONTROL AND EQUIVALENCE OF VARIOUS
... Conclusion: Product quality is the key issue for selection between generics, but how quality is assessed by pharmacists or other health practitioners is not very clear. Price differential between generics does not necessarily mean poor quality for the cheaper brand. It is obvious from the study that ...
... Conclusion: Product quality is the key issue for selection between generics, but how quality is assessed by pharmacists or other health practitioners is not very clear. Price differential between generics does not necessarily mean poor quality for the cheaper brand. It is obvious from the study that ...
Water Soluble Polymers for Pharmaceutical Applications
... from the body because it is not recognized as the foreign body. Therefore, the majority of conjugated drugs as well as liposomal and micellar formulations on the market or in advanced clinical trials are PEG-containing products [8]. Most of the polymer-based stealth drug-delivery systems that have r ...
... from the body because it is not recognized as the foreign body. Therefore, the majority of conjugated drugs as well as liposomal and micellar formulations on the market or in advanced clinical trials are PEG-containing products [8]. Most of the polymer-based stealth drug-delivery systems that have r ...
Sedative–hypnotic and Anxiolytic Drugs
... their rates of metabolism and excretion; redistribution away from the central nervous system is of primary importance in terminating their therapeutic effects. Although tissue redistribution of benzodiazepines may be an important means of terminating the actions of selected members of this class of ...
... their rates of metabolism and excretion; redistribution away from the central nervous system is of primary importance in terminating their therapeutic effects. Although tissue redistribution of benzodiazepines may be an important means of terminating the actions of selected members of this class of ...
... mentioned here, but our focus was on articles from the last 10 years. These articles were then grouped by common themes and summarized. This presentation does not necessarily represent anybody’s opinion, statement of fact, or any prevailing industry standards. These are just common ideas that we are ...
Treatment of Hypertension: Monotherapy or
... benefits, costs and consequences. In the United States, one out of every six adolescents is overweight; in Perú, 35% is overweight according to the Centro Nacional de Alimentación y Nutrición (CENAN 2009). In Lima, 66% eats fast food and 87% of the population nationwide eats fried food at least once ...
... benefits, costs and consequences. In the United States, one out of every six adolescents is overweight; in Perú, 35% is overweight according to the Centro Nacional de Alimentación y Nutrición (CENAN 2009). In Lima, 66% eats fast food and 87% of the population nationwide eats fried food at least once ...
The Basics of Drug Development Science
... The process is controlled by multiple factors • FDA regulations and guidances • Basic science of HIV infection • Evolving knowledge of what might work The basic science of drug development is a process to select the candidate(s) with the best chance of success ...
... The process is controlled by multiple factors • FDA regulations and guidances • Basic science of HIV infection • Evolving knowledge of what might work The basic science of drug development is a process to select the candidate(s) with the best chance of success ...
Bad Pharma
Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients is a book by British physician and academic Ben Goldacre about the pharmaceutical industry, its relationship with the medical profession, and the extent to which it controls academic research into its own products. The book was published in September 2012 in the UK by the Fourth Estate imprint of HarperCollins, and in February 2013 in the United States by Faber and Faber.Goldacre argues in the book that ""the whole edifice of medicine is broken"" because the evidence on which it is based is systematically distorted by the pharmaceutical industry. He writes that the industry finances most of the clinical trials into its own products and much of doctors' continuing education, that clinical trials are often conducted on small groups of unrepresentative subjects and negative data is routinely withheld, and that apparently independent academic papers may be planned and even ghostwritten by pharmaceutical companies or their contractors, without disclosure. Goldacre calls the situation a ""murderous disaster,"" and makes suggestions for action by patients' groups, physicians, academics and the industry itself.Responding to the book's publication, the Association of the British Pharmaceutical Industry issued a statement arguing that the examples the book offers are historical, that the concerns have been addressed, that the industry is among the most regulated in the world, and that it discloses all data in accordance with international standards.In January 2013 Goldacre joined the Cochrane Collaboration, British Medical Journal and others in setting up AllTrials, a campaign calling for the results of all past and current clinical trials to be reported. The British House of Commons Public Accounts Committee expressed concern in January 2014 that drug companies were still only publishing around 50 percent of clinical-trial results.