DISCLAIMER STATEMENT
... The purpose of this background document is to provide summary information on issues related to clinical trial designs and endpoints for community-acquired bacterial pneumonia (CABP) and describe outstanding issues where the FDA’s Anti-Infective Drugs Advisory Committee (AIDAC) can provide additional ...
... The purpose of this background document is to provide summary information on issues related to clinical trial designs and endpoints for community-acquired bacterial pneumonia (CABP) and describe outstanding issues where the FDA’s Anti-Infective Drugs Advisory Committee (AIDAC) can provide additional ...
Future Development Plan - sun pharma advanced research company
... © 2011 - Sun Pharma Advanced Research Company Limited (SPARC). All Rights Reserved ...
... © 2011 - Sun Pharma Advanced Research Company Limited (SPARC). All Rights Reserved ...
Polymers for Colon Targeted Drug Delivery Review Article
... diseases as well as systemic absorption of protein and peptides[1,2]. The colon is an ideal site for both systemic and local delivery of drugs. Treatment of large intestine disorders such as Crohn’s disease, irritable bowel syndrome, ulcerative colitis and colon cancer, where a high concentration of ...
... diseases as well as systemic absorption of protein and peptides[1,2]. The colon is an ideal site for both systemic and local delivery of drugs. Treatment of large intestine disorders such as Crohn’s disease, irritable bowel syndrome, ulcerative colitis and colon cancer, where a high concentration of ...
Sublimaze® CII (fentanyl citrate injection) - Akorn
... who have received MAO inhibitors within 14 days, appropriate monitoring and ready availability of vasodilators and beta-blockers for the treatment of hypertension is indicated. Head Injuries and Increased Intracranial Pressure — SUBLIMAZE should be used with caution in patients who may be particular ...
... who have received MAO inhibitors within 14 days, appropriate monitoring and ready availability of vasodilators and beta-blockers for the treatment of hypertension is indicated. Head Injuries and Increased Intracranial Pressure — SUBLIMAZE should be used with caution in patients who may be particular ...
(PSD) November 2015 PBAC Meeting
... The Australian Pain Society (APS), on the other hand, considered that there was a clinical need for additional strengths of oxycodone + naloxone at both the low and higher doses. The APS argued that the varied oxycodone + naloxone strengths would provide for greater flexibility in up- and down-titra ...
... The Australian Pain Society (APS), on the other hand, considered that there was a clinical need for additional strengths of oxycodone + naloxone at both the low and higher doses. The APS argued that the varied oxycodone + naloxone strengths would provide for greater flexibility in up- and down-titra ...
Guidelines
... higher to compensate for between-subject differences in absorption and elimination rate and thus enable accurate determination of the maximum concentration of the API in the blood (Cmax) and terminal elimination rate constant in all subjects Generally, sampling should continue for long enough to e ...
... higher to compensate for between-subject differences in absorption and elimination rate and thus enable accurate determination of the maximum concentration of the API in the blood (Cmax) and terminal elimination rate constant in all subjects Generally, sampling should continue for long enough to e ...
Profile of female patients seeking in-patient treatment for
... disorders has been reported to be high among women abusing prescription opioids. More specifically, the association between depressive and anxiety disorders and abuse of prescription opioids among women has been supported in earlier studies from west6,7. Choice of psychoactive substance, reasons for ...
... disorders has been reported to be high among women abusing prescription opioids. More specifically, the association between depressive and anxiety disorders and abuse of prescription opioids among women has been supported in earlier studies from west6,7. Choice of psychoactive substance, reasons for ...
PHAR 7633 Chapter 7 Routes of Drug Administration
... First-pass effect - drugs absorbed orally are transported to the general circulation via the liver. Thus drugs which are extensively metabolized will be metabolized in the liver during absorption. e.g. the propranolol oral dose is somewhat higher than the IV, the same is true for morphine. Both thes ...
... First-pass effect - drugs absorbed orally are transported to the general circulation via the liver. Thus drugs which are extensively metabolized will be metabolized in the liver during absorption. e.g. the propranolol oral dose is somewhat higher than the IV, the same is true for morphine. Both thes ...
NUROFEN PLUS
... Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. This product contains a nonsteroidal anti- inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if the patient is: over 60, has had stomach ulcers or bleeding problems, takes a bloo ...
... Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. This product contains a nonsteroidal anti- inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if the patient is: over 60, has had stomach ulcers or bleeding problems, takes a bloo ...
Drug Interaction and Food - KSU Faculty Member websites
... mechanisms (De Smet, 2002). In Saudi Arabia, survey of available literature revealed the lack of quality control and product standardization of the majority of the used herbal preparations which makes it difficult to establish safe administration of herbal products. I.2. The complex nature of herba ...
... mechanisms (De Smet, 2002). In Saudi Arabia, survey of available literature revealed the lack of quality control and product standardization of the majority of the used herbal preparations which makes it difficult to establish safe administration of herbal products. I.2. The complex nature of herba ...
AS A NEWER VENTURE IN FAST DISSOLVING DOSAGE FORMS
... has gained traction among consumers since the 2001 introduction of Pfizer's Listerine Pocket Packs. And now many OTC suppliers are banking on that consumer acceptance as they try to leverage the thin strip technology against a new generation of self-care remedies. There are currently several project ...
... has gained traction among consumers since the 2001 introduction of Pfizer's Listerine Pocket Packs. And now many OTC suppliers are banking on that consumer acceptance as they try to leverage the thin strip technology against a new generation of self-care remedies. There are currently several project ...
December
... as including a device each time oral liquid prescription medications are dispensed. NCPDP also reiterates that dose amounts should always use leading zeroes before the decimal point for amounts less than one, and should not use trailing zeroes after a decimal point on labels for oral liquid medicati ...
... as including a device each time oral liquid prescription medications are dispensed. NCPDP also reiterates that dose amounts should always use leading zeroes before the decimal point for amounts less than one, and should not use trailing zeroes after a decimal point on labels for oral liquid medicati ...
Master Thesis in Computer Science and Engineering
... find even more information hidden in a graph as shown by Johansson et al. [2]. These will however not be investigated because of time constraints but could be interesting to compare against the combination of signature descriptors together with bandits as used in this work. ...
... find even more information hidden in a graph as shown by Johansson et al. [2]. These will however not be investigated because of time constraints but could be interesting to compare against the combination of signature descriptors together with bandits as used in this work. ...
Use of Chemotherapy plus a Monoclonal Antibody (Trastuzumab
... Patients • Women with progressive metastatic breast cancer that overexpressed HER2 who had not previously received chemotherapy for metastatic disease were eligible for the study. • The level of expression of HER2 was determined by immunohistochemical analysis in a central laboratory. • Only patien ...
... Patients • Women with progressive metastatic breast cancer that overexpressed HER2 who had not previously received chemotherapy for metastatic disease were eligible for the study. • The level of expression of HER2 was determined by immunohistochemical analysis in a central laboratory. • Only patien ...
Incentive Salience and the Transition to Addiction
... Most adults have used a potentially addictive drug at least once in their lifetime, if caffeine, alcohol, and nicotine are included in addition to illicit drugs. In some cases, contact with a substance is so frequent and socially accepted that many in society fail to recognize it as a “drug.” Howeve ...
... Most adults have used a potentially addictive drug at least once in their lifetime, if caffeine, alcohol, and nicotine are included in addition to illicit drugs. In some cases, contact with a substance is so frequent and socially accepted that many in society fail to recognize it as a “drug.” Howeve ...
Datasheet Methylprednisolone Sodium Succinate
... Convulsions have been reported with concurrent use of methylprednisolone and cyclosporin. Since concurrent administration of these agents results in a mutual inhibition of metabolism, it is possible that convulsions and other adverse events associated with the individual use of either drug may be mo ...
... Convulsions have been reported with concurrent use of methylprednisolone and cyclosporin. Since concurrent administration of these agents results in a mutual inhibition of metabolism, it is possible that convulsions and other adverse events associated with the individual use of either drug may be mo ...
What Is Experimental Medical Treatment
... One out of eight women born today will develop breast cancer in her lifetime.1 Breast cancer is the second major cause of cancer death for women in the United States. 2 The American Cancer Society estimates that 180,200 women will be diagnosed with breast cancer and 43,900 women will die of breast c ...
... One out of eight women born today will develop breast cancer in her lifetime.1 Breast cancer is the second major cause of cancer death for women in the United States. 2 The American Cancer Society estimates that 180,200 women will be diagnosed with breast cancer and 43,900 women will die of breast c ...
Nanobodies
... ! Worldwide exclusive rights to commercialise Nanobody products in human healthcare ! ~25 programmes in the R&D pipeline ! Two products achieved clinical proof-of-concepts in RA ! 5 Nanobody products in the clinic - 2 Phase II & 3 Phase I ! Exclusive rights to >500 patent applications and grant ...
... ! Worldwide exclusive rights to commercialise Nanobody products in human healthcare ! ~25 programmes in the R&D pipeline ! Two products achieved clinical proof-of-concepts in RA ! 5 Nanobody products in the clinic - 2 Phase II & 3 Phase I ! Exclusive rights to >500 patent applications and grant ...
NEUROLOGICAL ADVERSE DRUG REACTIONS AND STATIN THERAPY Research Article
... about 2.5% to 91.7% of dyslipidemic patients use statin3. In US at least one third of all patients use statins, while 90% in Canada and 85% in Australia1,4 used these medications. In Malaysia, about 90% of cardiac patients use statin5. Although the benefits significantly associated to statin therapy ...
... about 2.5% to 91.7% of dyslipidemic patients use statin3. In US at least one third of all patients use statins, while 90% in Canada and 85% in Australia1,4 used these medications. In Malaysia, about 90% of cardiac patients use statin5. Although the benefits significantly associated to statin therapy ...
Low Molecular Weight Heparin and Warfarin or Rivaroxaban for the
... groups [recurrent thrombosis rivaroxaban 36/1731 (2.1%) versus LMWH/VKA 51/1718 (3.0%), bleeding 8.1% in both groups]. Based on the study this drug has been licensed and NICE approved for this indication. A further part of the study (Einstein-Extend) randomised patients who had finished treatment in ...
... groups [recurrent thrombosis rivaroxaban 36/1731 (2.1%) versus LMWH/VKA 51/1718 (3.0%), bleeding 8.1% in both groups]. Based on the study this drug has been licensed and NICE approved for this indication. A further part of the study (Einstein-Extend) randomised patients who had finished treatment in ...
Randomized, Double-blind, Placebo
... no significant differences between the primary outcome measure of the treatment groups (P = .25). Similar results were obtained with the per-protocol population showing a significant reduction of the UPDRS II/III scale scores (−4.4 and −2.8 for the placebo and CoQ10 groups [P⬍.001 and P=.03], respec ...
... no significant differences between the primary outcome measure of the treatment groups (P = .25). Similar results were obtained with the per-protocol population showing a significant reduction of the UPDRS II/III scale scores (−4.4 and −2.8 for the placebo and CoQ10 groups [P⬍.001 and P=.03], respec ...
Randomized, Double-blind, Placebo
... no significant differences between the primary outcome measure of the treatment groups (P = .25). Similar results were obtained with the per-protocol population showing a significant reduction of the UPDRS II/III scale scores (−4.4 and −2.8 for the placebo and CoQ10 groups [P⬍.001 and P=.03], respec ...
... no significant differences between the primary outcome measure of the treatment groups (P = .25). Similar results were obtained with the per-protocol population showing a significant reduction of the UPDRS II/III scale scores (−4.4 and −2.8 for the placebo and CoQ10 groups [P⬍.001 and P=.03], respec ...
ANAFRANIL® 25 mg Coated tablets, 75 mg Sustained
... are taking antidepressant medication. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. Antidepressants increased the risk of suicidal thinking and behaviour (suicidality) in shortterm studies in chi ...
... are taking antidepressant medication. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. Antidepressants increased the risk of suicidal thinking and behaviour (suicidality) in shortterm studies in chi ...
Bad Pharma
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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.