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Relative pharmacokinetics of three amikacin brands in onco-hemotologic pediatric patients experiencing febrile neutropeina

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Summary

Three commercially available brands of amikacin were investigated in aparallel study design for the assessment of comparative pharmacokinetics in pediatric oncology patients with chemotherapy-induced neutropenic febrile episode. Amikacin concentration in serum samples was determined by fluorescence polarization immunoassay method using Abbott TDx system. Computer software, PK II was used for computation of pharmacokinetic parameters of amikacin. The serum concentration of all brands nonsignificantly (p>0.05) varied at all time points, except at 1 and 2 hrs post dosing.

At 1hr post dosing, the serum concentration of brand II varied from rest of two brands. Whereas at 2 hr following I/V infusion brands II and I were statistically different. Highest serum concentration of 38.69±1.45 μ/ml was observed in case of brand III while brands I and II showed lower but not significantly different serum concentration values, i.e., 36.30±1.65 and 37.89±1.32 μ/ml, respectively when compared with brand I.

The other pharmacokinetic parameters of 3 brands found to have non-significant difference (P<0.05) except, t1/2α and CI of brands I and II that deviated statistically significant (p<0.01). The relative bioavailability of brand II and III as compared with brand I, considered as standard 86.17 and 96.86%, respectively falls within the accepted limits of ±20% required for the bioequivalence of any two brands.

Based upon findings of the present study, all these brands may be used interchangeably in oncology patients. Further studies, however are needed to determine whether the statistically elevated CI value in brand II is of any clinical significance.

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Authors and Affiliations

  1. Faculty of Pharmacy, University of the Punjab, Lahore, Pakistan

    Muhammad Jamshaid

  2. Department of Pharmacy, Shukat Khanum Memorial Trust Cancer, Lahore, Pakistan

    Samia Yousuf & Amir Ali Rizvi

  3. Department of Pharmacy, Islanmia University, Bahawalpur, Pakistan

    Nadeem Irfan Bukhari

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  1. Muhammad Jamshaid
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  2. Samia Yousuf
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  3. Nadeem Irfan Bukhari
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  4. Amir Ali Rizvi
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Jamshaid, M., Yousuf, S., Bukhari, N.I. et al. Relative pharmacokinetics of three amikacin brands in onco-hemotologic pediatric patients experiencing febrile neutropeina. Eur. J. Drug Metab. Pharmacokinet. 28, 1–6 (2003). https://doi.org/10.1007/BF03190860

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  • DOI: https://doi.org/10.1007/BF03190860

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