Cargando…

Application of microbiological assay to determine pharmaceutical equivalence of generic intravenous antibiotics

BACKGROUND: Demonstration of equivalent amounts of the same active pharmaceutical ingredient (API) between generic and innovator products (pharmaceutical equivalence) is a basic requirement of regulatory agencies for intravenous generic drugs prior to clinical use, and constitutes the pivotal point...

Descripción completa

Detalles Bibliográficos
Autores principales:	Zuluaga, Andres F, Agudelo, Maria, Rodriguez, Carlos A, Vesga, Omar
Formato:	Texto
Lenguaje:	English
Publicado:	BioMed Central 2009
Materias:	Research Article
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2640365/ https://www.ncbi.nlm.nih.gov/pubmed/19149891 http://dx.doi.org/10.1186/1472-6904-9-1

Ejemplares similares

Determination of Therapeutic Equivalence of Generic Products of Gentamicin in the Neutropenic Mouse Thigh Infection Model
por: Zuluaga, Andres F., et al.
Publicado: (2010)

Nontherapeutic equivalence of a generic product of imipenem-cilastatin is caused more by chemical instability of the active pharmaceutical ingredient (imipenem) than by its substandard amount of cilastatin
por: Agudelo, Maria, et al.
Publicado: (2019)

Demonstration of Therapeutic Equivalence of Fluconazole Generic Products in the Neutropenic Mouse Model of Disseminated Candidiasis
por: Gonzalez, Javier M., et al.
Publicado: (2015)

In vitro and in vivo comparison of the anti-staphylococcal efficacy of generic products and the innovator of oxacillin
por: Rodriguez, Carlos A, et al.
Publicado: (2010)

Pharmacodynamics of nine generic products of amikacin compared with the innovator in the neutropenic mouse thigh infection model
por: Zuluaga, Andres F., et al.
Publicado: (2015)

Impact on Bacterial Resistance of Therapeutically Nonequivalent Generics: The Case of Piperacillin-Tazobactam
por: Rodriguez, Carlos A., et al.
Publicado: (2016)

Pharmaceutical equivalency of locally and regionally manufactured generic pharmaceutical products in UAE
por: Al Ali, Lamia, et al.
Publicado: (2022)

Lack of microbiological concordance between bone and non-bone specimens in chronic osteomyelitis: an observational study
por: Zuluaga, Andrés F, et al.
Publicado: (2002)

A strain-independent method to induce progressive and lethal pneumococcal pneumonia in neutropenic mice
por: Zuluaga, Andres F, et al.
Publicado: (2015)

Antifungal pharmacodynamics: Latin America's perspective
por: Gonzalez, Javier M., et al.
Publicado: (2016)

A new pharmacodynamic approach to study antibiotic combinations against enterococci in vivo: Application to ampicillin plus ceftriaxone
por: Jimenez-Toro, Ivone, et al.
Publicado: (2020)

Neutropenia induced in outbred mice by a simplified low-dose cyclophosphamide regimen: characterization and applicability to diverse experimental models of infectious diseases
por: Zuluaga, Andres F, et al.
Publicado: (2006)

Optimization of culture conditions to obtain maximal growth of penicillin-resistant Streptococcus pneumoniae
por: Restrepo, Andrea V, et al.
Publicado: (2005)

Development and Validation of a Microbiological Agar Assay for Determination of Orbifloxacin in Pharmaceutical Preparation
por: Cazedey, Edith C. L., et al.
Publicado: (2011)

Clinical Equivalence between Generic Versus Branded Antibiotics: Systematic Review and Meta-Analysis
por: Cotia, André, et al.
Publicado: (2023)

Pharmaceutical Equivalence of Distributed Generic Antiretroviral (ARV) in Asian Settings: The Cross-Sectional Surveillance Study – PEDA Study
por: Sapsirisavat, Vorapot, et al.
Publicado: (2016)

Are antibiotics substandard in Lebanon? Quantification of active pharmaceutical ingredients between brand and generics of selected antibiotics
por: Hobeika, Eva, et al.
Publicado: (2020)

Pharmaceutical microbiology
Publicado: (1998)

Demonstration of Equivalence of Generic Glatiramer Acetate and Copaxone(®)
por: Lipsky, Peter, et al.
Publicado: (2021)

Evaluation of Biological Equivalence for Generic Tulathromycin Injections in Cattle
por: Kang, JeongWoo, et al.
Publicado: (2023)

Managing robotics in the generic pharmaceutical arena
por: Scheffler, Marianne
Publicado: (1992)

Demonstration of Biological and Immunological Equivalence of a Generic Glatiramer Acetate
por: D’Alessandro, Josephine, et al.
Publicado: (2017)

Assessment of the equivalence of a generic to a branded femoral stem
por: Hothi, H., et al.
Publicado: (2017)

Drugs Becoming Generics—The Impact of Genericization on the Market Performance of Antihypertensive Active Pharmaceutical Ingredients
por: Kovács, Bence, et al.
Publicado: (2021)

validated microbiological and HPLC methods for the determination of moxifloxacin in pharmaceutical preparations and human plasma
por: Abdelaziz, Ahmed A., et al.
Publicado: (2012)

Microbiological testing of pharmaceuticals and cosmetics in Egypt
por: Zeitoun, Hend, et al.
Publicado: (2015)

Assessing pricing and reimbursement policies for generic pharmaceuticals in the MENA region for improved efficiency, affordability and generic penetration
por: Kamphuis, Bregtje W., et al.
Publicado: (2021)

Withdrawal of two generic clopidogrel products in Saudi Arabia for non-bio-equivalence
por: Alsultan, Abdullah Saleh, et al.
Publicado: (2018)

Wixela Inhub: A Generic Equivalent Treatment Option for Patients with Asthma or COPD
por: Donohue, James F., et al.
Publicado: (2020)

From generic scheme to brand-generic scheme: Have new policy influenced the efficiency of Iranian pharmaceutical companies?
por: Hashemi-Meshkini, Amir, et al.
Publicado: (2014)

Microbiological quality of non-sterile pharmaceutical products
por: Ratajczak, M., et al.
Publicado: (2015)

Does China’s competitive generic substitution policy deliver equivalent clinical outcomes? A pilot study with two generic formulations of olanzepine
por: Zhang, Chao, et al.
Publicado: (2023)

Physicochemical equivalence of generic antihypertensive medicines (EQUIMEDS): protocol for a quality of medicines assessment
por: Redfern, Julie, et al.
Publicado: (2016)

Evaluating Therapeutic Equivalence of Generic and Original Levetiracetam in Patients with Epilepsy: A Retrospective Study
por: Tharavichitkun, Jannapas, et al.
Publicado: (2022)

Comparison of Pharmaceutical Characteristics between Brand-Name Meropenem and Its Generics
por: Yang, Ping, et al.
Publicado: (2021)

Evaluation of the exposure equivalence of oral versus intravenous temozolomide
por: Diez, Blanca D., et al.
Publicado: (2009)

Stability-Indicating HPLC Assay for Determination of Idebenone in Pharmaceutical Forms
por: Kombath, Sonoube, et al.
Publicado: (2015)

Simple mix-and-read assays for the determination of baclofen in pharmaceutical formulation
por: El-Yazbi, Amira F., et al.
Publicado: (2019)

TLC-smartphone in antibiotics determination and low-quality pharmaceuticals detection
por: Gad, Asmaa G., et al.
Publicado: (2021)

Resistance to In-Office Dispensing of Generic Antibiotic Samples
por: Kogut, Stephen J., et al.
Publicado: (2009)

Cannot write session to /tmp/vufind_sessions/sess_jbnu986ineuhtdfhsqitukejsk