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Interrelationship Between Pharmacokinetic and Pharmacodynamic Parameters as Determinants of Antibiotic Dosing and Correlation with Clinical Efficacy PDF
By:George Ignatius Moonsammy
Published on 2000 by

It is now established that pharmacokinetic/pharmacodynamic (PK/PD) parameters, such as the time that a beta-lactam antibiotic serum concentration exceeds the bacterial minimum inhibitory concentration (T\u003e MIC), can be used as predictors of clinical outcome. This theory was tested in reducing the dosing frequency of a commonly used beta-lactam antibiotic, amoxicillin-clavulanate (A/C) from three times (TID) to twice (BID daily. Pharmacokinetic, microbiological and in vivo animal studies have demonstrated that the T\u003e MIC for A/C-indicated organisms were similar for both T.I.D and B.I.D regimens. to test the PK/PD correlation with clinical efficacy, four large, multi-center, prospective, blinded, randomized clinical trials (3 adults, 1 pediatric), consisting of 1,936 patients were conducted to compare the efficacy and safety of the new B.I.D regimen with the standard T.I.D regimen. Adult patients with respiratory tract infections (pneumonia, bronchitis and sinusitis) and urinary tract infections received either A/C 875/125 mg B.I.D or the standard A/C 500/125 mg T.I.D formulation. Pediatric patients with ear infections received either the new A/C 45/6.4 mg/kg/day in divided doses B.I.D or the standard A/C 40/10 mg/kg/day in divided doses T.I.D. There were no significant differences in demographics and severity of disease among treatment groups. Clinical outcomes were determined at the end of therapy (EOT) and at follow up (FU) for both evaluable and intent-to-treat patients. At the EOT, the overall efficacy rates across infections for the B.I.D and T.I.D treatment groups were 470/524 (90%) and 471/544 (87%) and at F/U were 351/458 (77%) and 351/482 (74%) respectively. These differences were not statistically significant (p = 0.12 and 0.18, respectively). the results of these studies demonstrate that T\u003e MIC as a PK/PD parameter is a good predictor of clinical efficacy.

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Book ID of Interrelationship Between Pharmacokinetic and Pharmacodynamic Parameters as Determinants of Antibiotic Dosing and Correlation with Clinical Efficacy's Books is h9PgnQAACAAJ, Book which was written byGeorge Ignatius Moonsammyhave ETAG "/PCkxkmYnis"

Book which was published by since 2000 have ISBNs, ISBN 13 Code is 9780599682504 and ISBN 10 Code is 0599682507

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