Pharmaceutical Sciences Encyclopedia, Mar 15, 2010
Regulation of drugs by health institutions and governments ensures public protection from unsafe ... more Regulation of drugs by health institutions and governments ensures public protection from unsafe products. In parallel with the development of drug regulations, biological regulations were developed to enforce safety concerns of drugs. This article focuses on regulation enforced in development of small molecules, biological (vaccines), and biotech products. Keywords: public protection; safety concerns; drug regulations; biotech products
To assess the effectiveness of a Hib vaccination program against X-ray defined bacterial pneumoni... more To assess the effectiveness of a Hib vaccination program against X-ray defined bacterial pneumonia in children <2 years in Colombia. 389 cases of radiologically confirmed pneumonia were recruited from hospitals in Bogota and Medellin, Colombia. Two controls per case, matched on age, sex, and socio-economic level, were selected from children attending child health services at the hospitals where pneumonia cases were admitted. The risk of having X-ray confirmed pneumonia decreased with each Hib dose received; the vaccine effectiveness was 47% (2-72%) among those receiving one dose; 52% for two doses received, and 55% for three doses. These effectiveness levels remained after adjusting for other factors associated with risk of pneumonia. This study indicates that trials may have underestimated the proportion of radiological pneumonia in the under 2s that is due to Hib. This suggests that the impact of the vaccination will be greater than expected if it can be extended to reach the poorest children, who are at the greatest risk.
Objetivos. Explorar la alineación del contenido de los artículos publicados por la Revista Paname... more Objetivos. Explorar la alineación del contenido de los artículos publicados por la Revista Panamericana de Salud Pública durante sus 100 años de existencia, con los temas sanitarios claves de la Organización Panamericana de la Salud (OPS). Métodos. Se llevó a cabo un análisis bibliométrico con visualización de sus resultados. Se recuperó la información sobre los artículos publicados en la Revista a partir del Repositorio Institucional para Intercambio de Información (IRIS) de la OPS para los primeros 75 años y de Scopus para los últimos 25 años hasta febrero del 2022; para establecer los temas claves de la OPS se usaron referencias a documentos de los Cuerpos Directivos y declaraciones de los directores. Resultados. Se obtuvieron inicialmente 12 573 publicaciones y se consideraron para el análisis 9 289 para el período 1922 a 1996 y 3 208 para el período 1997 a 2022. Para el análisis bibliométrico de la información de Scopus se tuvieron en cuenta indicadores como los autores y su pr...
La integracion del cuidado de la salud individual con el de la poblacion a traves de la salud pub... more La integracion del cuidado de la salud individual con el de la poblacion a traves de la salud publica se ha podido llevar a cabo de forma efectiva a partir del modelo de la atencion primaria orientada a la comunidad. En Cuba, la atencion primaria es la base del sistema nacional de salud, con acceso universal y cuidado de los individuos, sus familias y la comunidad. El sistema nacional de salud y la atencion primaria orientada a la comunidad contribuyen a la mejora de la salud y a la disminucion de desigualdades en salud e iniquidades en la provision de servicios. Este articulo presenta su descripcion y analisis.
Objective. To assess the productivity and visibility in research, clinical studies, treatment, us... more Objective. To assess the productivity and visibility in research, clinical studies, treatment, use and production of antivenoms against poisonous snakes, scorpions and spiders. Method. Bibliometric analysis of research and other activities. Articles on venoms and antivenoms published between 2000 and 2020 were retrieved from the Scopus database. The records were analyzed by bibliometric indicators including number of documents per year, journals, authors, and citation frequency. VOSviewer® v.1.6.13 was used to construct bibliometric networks for country co-authorships and co-occurrence of terms. Results. Australia, Brazil, Costa Rica and India were among the six top countries with most documents and were selected for more detailed analysis. Costa Rica was the country with the largest percentage of its publications dedicated to antivenom production and venomics. Only a few papers dealt with the issues of quality, safety, and efficacy of antivenoms or the role of the national regulato...
Revista panamericana de salud pública = Pan American journal of public health, 2015
The objective of this study is to analyze the legal framework for health and intellectual propert... more The objective of this study is to analyze the legal framework for health and intellectual property in Cuba and its impacton people's access to health resources and on the roles of different social actors. The methods used were those developed by the Pan American Health Organization to implement the project of the Conceptual Map on Public Health and Intellectual Property. Information retrieved specifically on the legal framework for the National Health System, the Intellectual Property System and the strengthening of the country's biopharmaceutical industry-and on the…
Objetivo. Medir a través del análisis bibliométrico la productividad, la visibilidad y el impacto... more Objetivo. Medir a través del análisis bibliométrico la productividad, la visibilidad y el impacto del Sistema Regional de Vacunas (SIREVA, un proyecto de la Organización Panamericana de la Salud) en sus dos componentes, la vigilancia por laboratorio y el desarrollo de vacunas. Métodos. Se recuperaron de Scopus las publicaciones correspondientes a vigilancia por laboratorio y desarrollo de vacunas con sus referencias y citas y se aplicó la herramienta para obtener los indicadores bibliométricos. Se utilizó VOSviewer® 1.6.13 para visualizar las redes de coautoría por país y autores, y para realizar un análisis de coocurrencia de términos incluidos en los títulos y resúmenes de las publicaciones. Resultados. Cumplieron los criterios establecidos para vigilancia por laboratorio y desarrollo de vacunas 173 y 128 publicaciones, respectivamente. Diez países de la Región fueron responsables de 90,8% de las publicaciones sobre vigilancia por laboratorio y 8 países de todas las publicaciones ...
Access to safe, effective, quality-assured antivenom products that are tailored to endemic venomo... more Access to safe, effective, quality-assured antivenom products that are tailored to endemic venomous snake species is a crucial component of recent coordinated efforts to reduce the global burden of snakebite envenoming. Multiple access barriers may affect the journey of antivenoms from manufacturers to the bedsides of patients. Our review describes the antivenom ecosystem at different levels and identifies solutions to overcome these challenges. At the global level, there is insufficient manufacturing output to meet clinical needs, notably for antivenoms intended for use in regions with a scarcity of producers. At national level, variable funding and deficient regulation of certain antivenom markets can lead to the procurement of substandard antivenom. This is particularly true when producers fail to seek registration of their products in the countries where they should be used, or where weak assessment frameworks allow registration without local clinical evaluation. Out-of-pocket expenses by snakebite victims are often the main source of financing antivenoms, which results in the underuse or under-dosing of antivenoms, and a preference for low-cost products regardless of efficacy. In resource-constrained rural areas, where the majority of victims are bitten, supply of antivenom in peripheral health facilities is often unreliable. Misconceptions about treatment of snakebite envenoming are common, further reducing demand for antivenom and exacerbating delays in reaching facilities equipped for antivenom use. Multifaceted interventions are needed to improve antivenom access in resource-limited settings. Particular attention should be paid to the comprehensive list of actions proposed within the WHO Strategy for Prevention and Control of Snakebite Envenoming.
Iron starvation interferes drastically with the multiplication and virulence of Salmonella typhi ... more Iron starvation interferes drastically with the multiplication and virulence of Salmonella typhi mutants defective in enterochelin synthesis or enterochelin transport. Growth of these mutants is inhibited in the presence of human sera and unsaturated transferrin and is restored by fully saturated transferrin. The mutants exhibit decreased ability to grow in HeLa cell monolayers and are attenuated in mice. These findings are consistent with the S. typhi enterochelin system playing a role in the pathogenesis of typhoid fever.
Group B streptococci (GBS) are the most common cause of bacterial sepsis and meningitis in neonat... more Group B streptococci (GBS) are the most common cause of bacterial sepsis and meningitis in neonates in the United States. Although the capsular polysaccharide of GBS is an important virulence factor, it is variably immunogenic in humans. In this report, we have increased the immunogenicity of GBS type II polysaccharide by coupling it to tetanus toxoid (TT). Like other GBS capsular polysaccharides, the type II polysaccharide has side chains terminating in sialic acid. Controlled periodate oxidation of native II polysaccharide resulted in the conversion of 7% of sialic acid residues to an analog of sialic acid, 5-acetamido-3,5-dideoxy-D-galactosyloctulosonic acid. TT was conjugated to free aldehyde groups created on the oxidized sialic acid residues by reductive amination. Serum from rabbits vaccinated with type II-TT conjugate (II-TT) vaccine contained antibodies specific to type II polysaccharide as well as to TT, whereas rabbits vaccinated with uncoupled native type II polysacchari...
An antigenically distinct serotype, type IV, has recently been added to the recognized serotypes ... more An antigenically distinct serotype, type IV, has recently been added to the recognized serotypes of group B streptococci (GBS). We isolated and purified the capsular polysaccharide antigen from a prototype type IV GBS strain. The type IV capsular polysaccharide formed a precipitin line with rabbit antiserum to type IV GBS organisms but not with antiserum to organisms of GBS serotype Ia, Ib, II, or III. Enzyme-linked immunosorbent assay inhibition experiments showed no cross-reaction between type IV antiserum and other GBS serotypes. Capsular polysaccharide released from the bacterial cells with mutanolysin and that isolated from the culture supernatant had similar elution profiles on Sepharose CL-6B, with a Kav of 0.30 and an estimated Mr of 200,000. The purified type IV polysaccharide was found to contain galactose, glucose, N-acetylglucosamine, and N-acetylneuraminic acid (sialic acid) as exclusive sugars. The polysaccharide contained 23% (by weight) sialic acid and galactose, glu...
Polysaccharide of O:9,12 specificity purified from Salmonella typhi was conjugated to tetanus tox... more Polysaccharide of O:9,12 specificity purified from Salmonella typhi was conjugated to tetanus toxoid or bovine serum albumin in order to obtain defined antigenic material that would contain O chain free of other S. typhi antigens and that would be suitable for characterizing host humoral response to only S. typhi O-chain antigens. These artificial conjugates were strongly reactive in immunodots with 18 pooled and 3 individual serum samples from patients with typhoid fever and with rabbit anti-Salmonella O antiserum (group D, factors 1, 9, and 12). They reacted weakly with one serum sample from one human with paratyphoid A. These results suggest that the periodate oxidation and the reductive amination used in the conjugation conserved the immunogenicity of the O chain and allowed its absorption to nitrocellulose. They also suggest that the bovine serum albumin conjugate could be used in the diagnosis of S. typhi infections as normal sera may react with the protein molecule of the tet...
Pharmaceutical Sciences Encyclopedia, Mar 15, 2010
Regulation of drugs by health institutions and governments ensures public protection from unsafe ... more Regulation of drugs by health institutions and governments ensures public protection from unsafe products. In parallel with the development of drug regulations, biological regulations were developed to enforce safety concerns of drugs. This article focuses on regulation enforced in development of small molecules, biological (vaccines), and biotech products. Keywords: public protection; safety concerns; drug regulations; biotech products
To assess the effectiveness of a Hib vaccination program against X-ray defined bacterial pneumoni... more To assess the effectiveness of a Hib vaccination program against X-ray defined bacterial pneumonia in children <2 years in Colombia. 389 cases of radiologically confirmed pneumonia were recruited from hospitals in Bogota and Medellin, Colombia. Two controls per case, matched on age, sex, and socio-economic level, were selected from children attending child health services at the hospitals where pneumonia cases were admitted. The risk of having X-ray confirmed pneumonia decreased with each Hib dose received; the vaccine effectiveness was 47% (2-72%) among those receiving one dose; 52% for two doses received, and 55% for three doses. These effectiveness levels remained after adjusting for other factors associated with risk of pneumonia. This study indicates that trials may have underestimated the proportion of radiological pneumonia in the under 2s that is due to Hib. This suggests that the impact of the vaccination will be greater than expected if it can be extended to reach the poorest children, who are at the greatest risk.
Objetivos. Explorar la alineación del contenido de los artículos publicados por la Revista Paname... more Objetivos. Explorar la alineación del contenido de los artículos publicados por la Revista Panamericana de Salud Pública durante sus 100 años de existencia, con los temas sanitarios claves de la Organización Panamericana de la Salud (OPS). Métodos. Se llevó a cabo un análisis bibliométrico con visualización de sus resultados. Se recuperó la información sobre los artículos publicados en la Revista a partir del Repositorio Institucional para Intercambio de Información (IRIS) de la OPS para los primeros 75 años y de Scopus para los últimos 25 años hasta febrero del 2022; para establecer los temas claves de la OPS se usaron referencias a documentos de los Cuerpos Directivos y declaraciones de los directores. Resultados. Se obtuvieron inicialmente 12 573 publicaciones y se consideraron para el análisis 9 289 para el período 1922 a 1996 y 3 208 para el período 1997 a 2022. Para el análisis bibliométrico de la información de Scopus se tuvieron en cuenta indicadores como los autores y su pr...
La integracion del cuidado de la salud individual con el de la poblacion a traves de la salud pub... more La integracion del cuidado de la salud individual con el de la poblacion a traves de la salud publica se ha podido llevar a cabo de forma efectiva a partir del modelo de la atencion primaria orientada a la comunidad. En Cuba, la atencion primaria es la base del sistema nacional de salud, con acceso universal y cuidado de los individuos, sus familias y la comunidad. El sistema nacional de salud y la atencion primaria orientada a la comunidad contribuyen a la mejora de la salud y a la disminucion de desigualdades en salud e iniquidades en la provision de servicios. Este articulo presenta su descripcion y analisis.
Objective. To assess the productivity and visibility in research, clinical studies, treatment, us... more Objective. To assess the productivity and visibility in research, clinical studies, treatment, use and production of antivenoms against poisonous snakes, scorpions and spiders. Method. Bibliometric analysis of research and other activities. Articles on venoms and antivenoms published between 2000 and 2020 were retrieved from the Scopus database. The records were analyzed by bibliometric indicators including number of documents per year, journals, authors, and citation frequency. VOSviewer® v.1.6.13 was used to construct bibliometric networks for country co-authorships and co-occurrence of terms. Results. Australia, Brazil, Costa Rica and India were among the six top countries with most documents and were selected for more detailed analysis. Costa Rica was the country with the largest percentage of its publications dedicated to antivenom production and venomics. Only a few papers dealt with the issues of quality, safety, and efficacy of antivenoms or the role of the national regulato...
Revista panamericana de salud pública = Pan American journal of public health, 2015
The objective of this study is to analyze the legal framework for health and intellectual propert... more The objective of this study is to analyze the legal framework for health and intellectual property in Cuba and its impacton people's access to health resources and on the roles of different social actors. The methods used were those developed by the Pan American Health Organization to implement the project of the Conceptual Map on Public Health and Intellectual Property. Information retrieved specifically on the legal framework for the National Health System, the Intellectual Property System and the strengthening of the country's biopharmaceutical industry-and on the…
Objetivo. Medir a través del análisis bibliométrico la productividad, la visibilidad y el impacto... more Objetivo. Medir a través del análisis bibliométrico la productividad, la visibilidad y el impacto del Sistema Regional de Vacunas (SIREVA, un proyecto de la Organización Panamericana de la Salud) en sus dos componentes, la vigilancia por laboratorio y el desarrollo de vacunas. Métodos. Se recuperaron de Scopus las publicaciones correspondientes a vigilancia por laboratorio y desarrollo de vacunas con sus referencias y citas y se aplicó la herramienta para obtener los indicadores bibliométricos. Se utilizó VOSviewer® 1.6.13 para visualizar las redes de coautoría por país y autores, y para realizar un análisis de coocurrencia de términos incluidos en los títulos y resúmenes de las publicaciones. Resultados. Cumplieron los criterios establecidos para vigilancia por laboratorio y desarrollo de vacunas 173 y 128 publicaciones, respectivamente. Diez países de la Región fueron responsables de 90,8% de las publicaciones sobre vigilancia por laboratorio y 8 países de todas las publicaciones ...
Access to safe, effective, quality-assured antivenom products that are tailored to endemic venomo... more Access to safe, effective, quality-assured antivenom products that are tailored to endemic venomous snake species is a crucial component of recent coordinated efforts to reduce the global burden of snakebite envenoming. Multiple access barriers may affect the journey of antivenoms from manufacturers to the bedsides of patients. Our review describes the antivenom ecosystem at different levels and identifies solutions to overcome these challenges. At the global level, there is insufficient manufacturing output to meet clinical needs, notably for antivenoms intended for use in regions with a scarcity of producers. At national level, variable funding and deficient regulation of certain antivenom markets can lead to the procurement of substandard antivenom. This is particularly true when producers fail to seek registration of their products in the countries where they should be used, or where weak assessment frameworks allow registration without local clinical evaluation. Out-of-pocket expenses by snakebite victims are often the main source of financing antivenoms, which results in the underuse or under-dosing of antivenoms, and a preference for low-cost products regardless of efficacy. In resource-constrained rural areas, where the majority of victims are bitten, supply of antivenom in peripheral health facilities is often unreliable. Misconceptions about treatment of snakebite envenoming are common, further reducing demand for antivenom and exacerbating delays in reaching facilities equipped for antivenom use. Multifaceted interventions are needed to improve antivenom access in resource-limited settings. Particular attention should be paid to the comprehensive list of actions proposed within the WHO Strategy for Prevention and Control of Snakebite Envenoming.
Iron starvation interferes drastically with the multiplication and virulence of Salmonella typhi ... more Iron starvation interferes drastically with the multiplication and virulence of Salmonella typhi mutants defective in enterochelin synthesis or enterochelin transport. Growth of these mutants is inhibited in the presence of human sera and unsaturated transferrin and is restored by fully saturated transferrin. The mutants exhibit decreased ability to grow in HeLa cell monolayers and are attenuated in mice. These findings are consistent with the S. typhi enterochelin system playing a role in the pathogenesis of typhoid fever.
Group B streptococci (GBS) are the most common cause of bacterial sepsis and meningitis in neonat... more Group B streptococci (GBS) are the most common cause of bacterial sepsis and meningitis in neonates in the United States. Although the capsular polysaccharide of GBS is an important virulence factor, it is variably immunogenic in humans. In this report, we have increased the immunogenicity of GBS type II polysaccharide by coupling it to tetanus toxoid (TT). Like other GBS capsular polysaccharides, the type II polysaccharide has side chains terminating in sialic acid. Controlled periodate oxidation of native II polysaccharide resulted in the conversion of 7% of sialic acid residues to an analog of sialic acid, 5-acetamido-3,5-dideoxy-D-galactosyloctulosonic acid. TT was conjugated to free aldehyde groups created on the oxidized sialic acid residues by reductive amination. Serum from rabbits vaccinated with type II-TT conjugate (II-TT) vaccine contained antibodies specific to type II polysaccharide as well as to TT, whereas rabbits vaccinated with uncoupled native type II polysacchari...
An antigenically distinct serotype, type IV, has recently been added to the recognized serotypes ... more An antigenically distinct serotype, type IV, has recently been added to the recognized serotypes of group B streptococci (GBS). We isolated and purified the capsular polysaccharide antigen from a prototype type IV GBS strain. The type IV capsular polysaccharide formed a precipitin line with rabbit antiserum to type IV GBS organisms but not with antiserum to organisms of GBS serotype Ia, Ib, II, or III. Enzyme-linked immunosorbent assay inhibition experiments showed no cross-reaction between type IV antiserum and other GBS serotypes. Capsular polysaccharide released from the bacterial cells with mutanolysin and that isolated from the culture supernatant had similar elution profiles on Sepharose CL-6B, with a Kav of 0.30 and an estimated Mr of 200,000. The purified type IV polysaccharide was found to contain galactose, glucose, N-acetylglucosamine, and N-acetylneuraminic acid (sialic acid) as exclusive sugars. The polysaccharide contained 23% (by weight) sialic acid and galactose, glu...
Polysaccharide of O:9,12 specificity purified from Salmonella typhi was conjugated to tetanus tox... more Polysaccharide of O:9,12 specificity purified from Salmonella typhi was conjugated to tetanus toxoid or bovine serum albumin in order to obtain defined antigenic material that would contain O chain free of other S. typhi antigens and that would be suitable for characterizing host humoral response to only S. typhi O-chain antigens. These artificial conjugates were strongly reactive in immunodots with 18 pooled and 3 individual serum samples from patients with typhoid fever and with rabbit anti-Salmonella O antiserum (group D, factors 1, 9, and 12). They reacted weakly with one serum sample from one human with paratyphoid A. These results suggest that the periodate oxidation and the reductive amination used in the conjugation conserved the immunogenicity of the O chain and allowed its absorption to nitrocellulose. They also suggest that the bovine serum albumin conjugate could be used in the diagnosis of S. typhi infections as normal sera may react with the protein molecule of the tet...
Uploads
Papers by Jose Luis Di Fabio