Search Results for "Atorvastatin Bioequivalence Study"
Original Source: Bioequivalence Study Comparing A New 80 Mg Atorvastatin Tablet To A 80 Mg Atorvastatin Commercial Tablet
To determine whether new 80 mg atorvastatin tablets are bioequivalent to 80 mg commercial atorvastatin tablets (Lipitor®).
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SERAPHIN - STUDY WITH ENDOTHELIN RECEPTOR ANTAGONIST IN PULMONARY ARTERIAL HYPERTENSION TO IMPROVE CLINICAL OUTCOME. SERAPHIN (Study with an Endothelin Rece...
Statins (HMG-CoA reductase inhibitors) - a class of drug used to lower cholesterol levels
Statins (or HMG-CoA reductase inhibitors) are a class of drug used to lower cholesterol levels by inhibiting the enzyme HMG-CoA reductase, which plays a central role in the production of cholesterol...
Hepatology is the study of liver, gallbladder, biliary tree, and pancreas, and diseases associated with them. This includes viral hepatitis, alcohol damage, cirrhosis and cancer. As modern lifestyle...
Lipitor was the best selling drug in 2009, with the 2009 annual sales coming in at over $5m for its company, Pfizer Inc. Lipitor is the brand name for an atorvastatin calcium medication that is pres...
Pain is defined by the International Association for the Study of Pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in term...
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Greater drop in LDL seen with atorvastatin plus PCSK9 antibody
(HealthDay)—Addition of the fully human serum proprotein convertase subtilisin/kexin 9 monoclonal antibody, SAR236553, to atorvastatin is associated with greater reductions in low-density lipoprotei...
Efficacy and Safety of Atorvastatin in CIS
Dr. Hans-Christoph Diener discusses a study assessing atorvastatin in treating clinically isolated syndrome. Medscape Neurology
FDA Approving More ANDAs That Use Novel Bioequivalence Methods
OGD officials report on the progress being made in approving generic drugs using more novel and science-based bioequivalence methods than in the past. Officials impart tips on how to submit review-rea...
Azaya Therapeutics commences ATI-0918 bioequivalence study in ovarian cancer
Azaya Therapeutics, Inc. today announced the initiation of a bioequivalence study of ATI-0918 in patients with ovarian cancer.
Teva won’t sell generic atorvastatin
Teva has decided not to market its own generic version of Lipitor (atorvastatin), Pfizer’s blockbuster cholesterol-lowering drug that recently came off patent. The decision comes despite the fact th...
FDA Statement on the Ranbaxy Atorvastatin Recall
[11/29/2012] On Nov. 9, 2012, Ranbaxy Pharmaceuticals informed its customers of a voluntary recall of certain lots of the company’s 10mg, 20mg, and 40mg dosage strengths of atorvastatin tablets....
Initiating Atorvastatin in Severe Sepsis Isn't Helpful: Study
Starting atorvastatin in critically ill patients with severe sepsis did not reduce inflammation or improve survival in a phase II study from the ANZICS Clinical Trials Group. Reuters Health Informat...
New data shows value of morphologically directed Raman spectroscopy for bioequivalence studies
A new application note on the Malvern Instruments website describes the use of morphologically directed Raman microscopy in assessing the bioequivalence of a generic and innovator drug with a dual act...
Matching PubMed Articles
A simple liquid chromatography/ion trap mass spectrometry method for the quantification of amlodipine and atorvastatin with its metabolites, ortho and para hydroxy atorvastatin, simultaneously in huma...
In the European Union multiple dose bioequivalence studies are required for the approval of generic prolonged-release products, but they are not required by the US-FDA. In order to investigate if the...
Pharmacodynamic bioequivalence testing.
What is known and Objective: The assessment of bioequivalence of drugs intended for local action/targeted delivery and with poor systemic absorption presents unique challenges. Approaches such as p...
No clinically relevant drug-drug interactions when dalcetrapib is co-administered with atorvastatin.
Objectives: Dalcetrapib, which targets cholesteryl ester transfer protein, is in clinical development for prevention of cardiovascular events and is likely to be used concomitantly with statins. Two s...
UGT1A1*28 is Associated with Decreased Systemic Exposure of Atorvastatin Lactone.
BACKGROUND: Atorvastatin is commonly used to reduce cholesterol. Atorvastatin acid is converted to its corresponding lactone form spontaneously or via glucuronidation mediated by uridine diphosphate g...
