Current Regulatory Requirements for Biosimilars in Six Member Countries of BRICS-TM: Challenges and Opportunities

por Rahalkar, Hasumati, Sheppard, Alan, Santos, Gustavo Mendes Lima, Dasgupta, Chitralekha, Perez-Tapia, Sonia Mayra, Lopez-Morales, Carlos A., Salek, Sam
Publicado 2021

Regulatory Pathway for Licensing Biotherapeutics in Mexico

por López-Morales, Carlos A., Tenorio-Calvo, Alejandra, Cruz-Rodríguez, Rodolfo, Sánchez y Tepoz, Julio, Belgharbi, Lahouari, Pérez-Tapia, Sonia Mayra, Medina-Rivero, Emilio
Publicado 2018

Validation of three viable-cell counting methods: Manual, semi-automated, and automated

por Cadena-Herrera, Daniela, Esparza-De Lara, Joshua E., Ramírez-Ibañez, Nancy D., López-Morales, Carlos A., Pérez, Néstor O., Flores-Ortiz, Luis F., Medina-Rivero, Emilio
Publicado 2015

Validation of a Cell Proliferation Assay to Assess the Potency of a Dialyzable Leukocyte Extract Intended for Batch Release

por Carballo-Uicab, Gregorio, Linares-Trejo, José E., Mellado-Sánchez, Gabriela, López-Morales, Carlos A., Velasco-Velázquez, Marco, Pavón, Lenin, Estrada-Parra, Sergio, Pérez-Tapia, Sonia Mayra, Medina-Rivero, Emilio
Publicado 2019

Assessment of Physicochemical Properties of Rituximab Related to Its Immunomodulatory Activity

por Miranda-Hernández, Mariana P., López-Morales, Carlos A., Ramírez-Ibáñez, Nancy D., Piña-Lara, Nelly, Pérez, Nestor O., Molina-Pérez, Aarón, Revilla-Beltri, Jorge, Flores-Ortiz, Luis F., Medina-Rivero, Emilio
Publicado 2015

New Alternatives for Autoimmune Disease Treatments: Physicochemical and Clinical Comparability of Biosimilar Etanercept

por Miranda-Hernández, Mariana P., López-Morales, Carlos A., Perdomo-Abúndez, Francisco C., Salazar-Flores, Rodolfo D., Ramírez-Ibanez, Nancy D., Pérez, Nestor O., Molina-Pérez, Aarón, Revilla-Beltri, Jorge, Flores-Ortiz, Luis F., Medina-Rivero, Emilio
Publicado 2016

Response to: Comment on “New Alternatives for Autoimmune Disease Treatments: Physicochemical and Clinical Comparability of Biosimilar Etanercept”

por Miranda-Hernández, Mariana P., López-Morales, Carlos A., Perdomo-Abúndez, Francisco C., Salazar-Flores, Rodolfo D., Ramírez-Ibanez, Nancy D., Pérez, Nestor O., Molina-Pérez, Aaron, Revilla-Beltri, Jorge, Medina-Rivero, Emilio, Flores-Ortiz, Luis F.
Publicado 2018

Determination of Peptide Profile Consistency and Safety of Collagen Hydrolysates as Quality Attributes

por López‐Morales, Carlos A., Vázquez‐Leyva, Said, Vallejo‐Castillo, Luis, Carballo‐Uicab, Gregorio, Muñoz‐García, Leslie, Herbert‐Pucheta, José Enrique, Zepeda‐Vallejo, L. Gerardo, Velasco‐Velázquez, Marco, Pavón, Lenin, Pérez‐Tapia, Sonia M., Medina‐Rivero, Emilio
Publicado 2019

Taking advantage of a high-throughput flow cytometer for the implementation of an ADCC assay for regulatory compliance

por Camacho-Sandoval, Rosa, Jiménez-Uribe, Alexis, Tenorio-Calvo, Alejandra V., López-Morales, Carlos A., Muñoz-García, Leslie, Montes-Luna, Alejandra, García-Xolalpa, Héctor Leonardo, Velasco-Velázquez, Marco, Pavón, Lenin, Pérez-Tapia, Sonia Mayra, Medina-Rivero, Emilio
Publicado 2020

Physicochemical and Biological Characterization of a Biosimilar Trastuzumab

por López-Morales, Carlos A., Miranda-Hernández, Mariana P., Juárez-Bayardo, L. Carmina, Ramírez-Ibáñez, Nancy D., Romero-Díaz, Alexis J., Piña-Lara, Nelly, Campos-García, Víctor R., Pérez, Néstor O., Flores-Ortiz, Luis F., Medina-Rivero, Emilio
Publicado 2015

Pharmacokinetic Comparability of a Biosimilar Trastuzumab Anticipated from Its Physicochemical and Biological Characterization

por Miranda-Hernández, Mariana P., López-Morales, Carlos A., Piña-Lara, Nelly, Perdomo-Abúndez, Francisco C., Pérez, Néstor O., Revilla-Beltri, Jorge, Molina-Pérez, Aarón, Estrada-Marín, Larisa, Flores-Ortiz, Luis F., Ruiz-Argüelles, Alejandro, Medina-Rivero, Emilio
Publicado 2015

Validation of a cell-based colorimetric reporter gene assay for the evaluation of Type I Interferons

por Mejía-Calvo, Ignacio, Muñoz-García, Leslie, Jiménez-Uribe, Alexis, Camacho-Sandoval, Rosa, González-González, Edith, Mellado-Sánchez, Gabriela, Tenorio-Calvo, Alejandra V., López-Morales, Carlos A., Velasco-Velázquez, Marco A., Pavón, Lenin, Pérez-Tapia, Sonia Mayra, Medina-Rivero, Emilio
Publicado 2019

Quality attributes of partially hydrolyzed collagen in a liquid formulation used for skin care

por Mejía‐Calvo, Ignacio, López‐Juárez, Leonardo E., Vázquez‐Leyva, Said, López‐Morales, Carlos A., Montoya‐Escutia, Daniel, Merlos Rivera, Pamela G., Herbert‐Pucheta, José Enrique, Zepeda‐Vallejo, Luis Gerardo, Velasco‐Velázquez, Marco, Pavón, Lenin, Pérez‐Tapia, Sonia M., Medina‐Rivero, Emilio
Publicado 2020