Determination of therapeutic equivalence of generic products of gentamicin in the neutropenic mouse thigh infection model

Drug regulatory agencies (DRA) support prescription of generic products of intravenous antibiotics assuming therapeutic equivalence from pharmaceutical equivalence. Recent reports of deaths associated with generic heparin and metoprolol have raised concerns about the efficacy and safety of DRA-appro...

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Bibliographic Details
Published in:PloS one 2010-05, Vol.5 (5), p.e10744
Main Authors: Zuluaga, Andres F, Agudelo, Maria, Cardeño, John J, Rodriguez, Carlos A, Vesga, Omar
Format: Article
Language:English
Subjects:
Aminoglycosides
Animals
Anti-Infective Agents - pharmacology
Antibiotics
Anticoagulants
Antimicrobial agents
Aqueous solutions
Bacterial Infections - complications
Design
Disease Models, Animal
Drugs
Drugs, Generic - pharmacokinetics
Drugs, Generic - pharmacology
Drugs, Generic - therapeutic use
E coli
Effectiveness
Equivalence
Escherichia coli
Failure
Generic drugs
Generic products
Gentamicin
Gentamicins - pharmacokinetics
Gentamicins - pharmacology
Gentamicins - therapeutic use
Glycine max
Health aspects
Heparin
In vivo methods and tests
Independent regulatory commissions
Infections
Infectious Diseases/Antimicrobials and Drug Resistance
Infectious Diseases/Bacterial Infections
Innovations
Intravenous administration
Liver
Medical innovations
Medical research
Medical schools
Metoprolol
Mice
Microbial Sensitivity Tests
Minimum inhibitory concentration
Neutropenia
Neutropenia - complications
Neutropenia - drug therapy
Neutropenia - microbiology
Organ Specificity - drug effects
Organs
Pharmaceuticals
Pharmacology
Pharmacology/Drug Development
Pharmacology/Drug Resistance
Powder
Pseudomonas aeruginosa
Regulatory agencies
Reproducibility of Results
Staphylococcus aureus
Staphylococcus infections
Studies
Survival Analysis
Therapeutic Equivalency
Thigh
Thigh - microbiology
Thigh - pathology
Toxicology
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Description
Summary:Drug regulatory agencies (DRA) support prescription of generic products of intravenous antibiotics assuming therapeutic equivalence from pharmaceutical equivalence. Recent reports of deaths associated with generic heparin and metoprolol have raised concerns about the efficacy and safety of DRA-approved drugs. To challenge the assumption that pharmaceutical equivalence predicts therapeutic equivalence, we determined in vitro and in vivo the efficacy of the innovator product and 20 pharmaceutically equivalent generics of gentamicin. The data showed that, while only 1 generic product failed in vitro (MIC = 45.3 vs. 0.7 mg/L, P
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0010744