GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW) | ||||||
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19:57 Jan 7, 2011 |
German to English translations [PRO] Medical - Medical: Pharmaceuticals | |||||||
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| Selected response from: Marga Shaw United Kingdom Local time: 18:22 | ||||||
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Summary of answers provided | ||||
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4 +1 | Free Dose Combination |
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3 +1 | free combination of ... |
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Free Dose Combination Explanation: Some examples: "Janumet, a fixed dose combination of sitagliptin/metformin HCL manufactured by Merck Pharmaceuticals, has received US Food and Drug Administration approval for treatment of patients with type 2 diabetes, that are inadequately controlled, either by sitagliptin or metformin alone or together in free-dose combination form" Racial differences in medication compliance and healthcare utilization among hypertensive medicaid recipients: fixed-dose vs free dose combination treatment. German: "In der Regel ist die freie Kombination der Wirkstoffe kostengünstiger als die feste Kombination" Example sentence(s):
Reference: http://www.ionchannels.org/showabstract.php?pmid=18507275 |
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free combination of ... Explanation: a free combination of trandolapril and isoptin e.g.: The combination contains known active substances and it is a substitution indication (i.e. use in patients adequately controlled with the individual products given concurrently, at the same dose level as in the combination, but as separate tablets) or the new fixed combination contains known active ingredients that have not been used in combination before. In these cases bioequivalence should be demonstrated between the free combination of the recognised reference formulations of the individual monocomponents and the marketing formulation (fixed combination). http://www.tga.gov.au/docs/pdf/euguide/ewp/024095enfin.pdf (a) Comparison of blood pressure goal achievement between patients receiving valsartan-based single pill combinations and those receiving angiotensin receptor-blocker-based free combinations. (b) Comparison of blood pressure goal achievement between patients receiving single pill combination of valsartan/amlodipine and those receiving free combination of angiotensin receptor blocker þ calcium channel blocker. (c) Comparison of blood pressure goal achievement between patients receiving single-pill combination of valsartan/ hydrochlorothiazide and those receiving free combinations of angiotensin receptor blocker þ hydrochlorothiazide. http://docs.google.com/viewer?a=v&q=cache:JLenw8NLKFAJ:www.i... Bioequivalence studies [CP-study 2303 and CP-study 2309] compared the fixed combination valsartan/amlodipine tablet against the free combination of clinical service forms (CSFs) of valsartan and amlodipine. The amlodipine CSF was an encapsulated US-sourced amlodipine tablet. http://docs.google.com/viewer?a=v&q=cache:I-vF9Vx9lFkJ:www.e... |
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