Non-Equivalence of Antibiotic Generic Drugs and Risk for Intensive Care Patients

C, James Kirkpatrick

doi:10.4172/2167-7689.1000109

Cited by 3 publications

(2 citation statements)

References 33 publications

(48 reference statements)

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“…This underscore the need of redefining the regulatory rules before the marketing authorization is given to certain antibiotics, as it has been recently suggested [19].…”

Section: Discussionmentioning

confidence: 94%

Group A2 Analogs of Innovator Teicoplanin: Variability of their Ratio during Treatment Time Course in Human Blood; Consequences for the Generics

P¹

2013

Pharmaceut Reg Affairs

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Absence of therapeutic equivalence (TE) of generic antibiotics versus the innovator has been reported, even in case of pharmaceutical equivalence (PE).The pharmaceutically active principle of teicoplanin is mainly represented by the A2 group analogs (A2-1 to A2-2) which exist in given ratios in the innovator.We studied the evolution of these ratios in humans volunteers receiving 2 dosage regimen (6mg/kg IV every 12 hours, 3 times, and then 6 mg/kg per day for ten days -group1-, and 12 mg/kg IV every 12h, 3 times, followed by 15 mg/kg every other day till D11 -group 2-), by a specific HPLC methodology, after single dose (D1) and at steady state at day 11(D11).The less lipophilic analogs A2-1, A2-2, and A2-3 percentage decreases respectively were 18%, 11%, and 21% (group 1) and 34%, 14%, and 15% (group 2) between D1 and D11 for trough concentrations. At the same time, the more lipophilic A2-4 and A2-5 analogs ratio increases respectively were 15% and 19% (group 1) and 13% and 30% (group 2). These variations raise the problem of generics having the same global qualitative composition of analogs (PE) but with differing initial ratios. The bactericidal activity of innovator teicoplanin is optimal at its own ratios of the different analogs that act in a synergistic manner. Regarding generics, it would lead to final ratio in blood and tissues that are at risk of a sub optimal bactericidal activity. Thus, concluding in bioequivalence and therapeutic equivalence of these generics with the innovator remains highly questionable.

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“…This underscore the need of redefining the regulatory rules before the marketing authorization is given to certain antibiotics, as it has been recently suggested [19].…”

Section: Discussionmentioning

confidence: 94%

Group A2 Analogs of Innovator Teicoplanin: Variability of their Ratio during Treatment Time Course in Human Blood; Consequences for the Generics

P¹

2013

Pharmaceut Reg Affairs

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“…Cells were cultured in 199 medium (Lonza) supplemented with 10% fetal calf serum (FCS, Nutricell, Campinas, SP, Brazil) at 37ºC with 5% CO 2 . Vero cells are recommended for studies of cytotoxicity and cell-substrate interactions is with biomaterials [12,13]. The culture medium was replaced whenever had the acidification of it.…”

Section: Methodsmentioning

confidence: 99%

Acellular Dermis Obtainment to Fibroblastic Cell Culture and Tissue Engineering

Ribeiro

Higa

Santos

2014

MSF

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Tissue injuries are the main factors that lead to treatment by skin culture. In cases where the damage is extensive patient has insufficient amount of tissue to recover the area lost. A possible solution is the use of tissue engineering. Dermal substitutes must provide features and functions as close as possible to the normal skin. The acellular dermis can be obtained from the own patient and represents a viable alternative as a graft. The acellular dermis is used as a dermal analogue to the implantation of cells for tissue engineering treatment. The aim of this study was to compare different ways of obtaining mouse skin acellular dermis and characterize this dermis by macroscopic visualization, light and atomic force microscopy and cell culture.

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Pharmaceutical quality of eight generics of ceftriaxone preparation for injection in Eastern Asia

Arnet

Altermatt

Roggo

et al. 2014

Journal of Chemotherapy

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Non-Equivalence of Antibiotic Generic Drugs and Risk for Intensive Care Patients

Cited by 3 publications

References 33 publications

Group A2 Analogs of Innovator Teicoplanin: Variability of their Ratio during Treatment Time Course in Human Blood; Consequences for the Generics

Group A2 Analogs of Innovator Teicoplanin: Variability of their Ratio during Treatment Time Course in Human Blood; Consequences for the Generics

Acellular Dermis Obtainment to Fibroblastic Cell Culture and Tissue Engineering

Pharmaceutical quality of eight generics of ceftriaxone preparation for injection in Eastern Asia

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