International Journal of Drug Development and Research

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General Safety Test and the Rabbit Pyrogen Test in the Quality Control of Biopharmaceuticals

Joint Event on 23rd International Conference and Exhibition on PHARMACEUTICAL FORMULATIONS & 13th International Conference and Exhibition on PHARMACOVIGILANCE & DRUG SAFETY
July 27-28, 2020 | Webinar

Pardo-Ruiz Z

Center for the State Control of Drugs, Equipment and Medical Devices, Cuba

Posters & Accepted Abstracts: Int J Drug Dev & Res


The use of alternative methods to animal testing has been encouraged, thus during the last decade an increasing number of alternative approaches in the biopharmaceutical industry have been formally adopted. In this context, there is an ethical, scientific and economic discussion worldwide in relation to the reliability of the application of the General Safety Test and the Rabbit Pyrogenic Test in the quality control of biopharmaceuticals. The application of the former has been questioned because no reliable conclusions can be drawn from this test. For this reason, this assay has been removed from some pharmacopeia’s and it is no longer mandatory for several Regulatory Agencies, especially after the introduction of Good Manufacturing Practices and the use of other stringent methods. In addition, in vitro alternatives for pyrogens control, such as the Monocyte Activation Test, have been developed. This alternative method mimics the human fever reactions and detects the enhancing pro-inflammatory effect of substances that are commonly found in the biopharmaceutical industry, increasing the product safety. It is known that the position of a Regulatory Authority is focused in the assurance on the safety of products; however, Cuban regulations have not yet specifically ruled on the usefulness of both tests. This work offers a scientific basis on the reliability of these tests and their role to increase or not the safety of biological products. In addition, the position of the Cuban Regulatory Authority with respect to its application in the quality control of biological products is exposed.
Recent Publications:
1. B. Garrido-Suárez, G. Garrido, M. Castro-Labrada, Z. Pardo-Ruiz, A. Bellma-Menéndez, E. Spencer, J. Godoy-Figueiredo, S. Ferreira, R. Delgado-Hernández. Anti-allodynic effect of Mangiferin in rats with chronic post-ischemia pain: a model of complex regional pain syndrome type I. Frontiers in Pharmacology 9:1119 (2018).
2. Montero-Alejo V, Corzo G, Porro-Suardíaz J, Pardo-Ruiz Z, Perera E, Rodríguez- Viera L, Sánchez-Díaz G, Hernández-Rodríguez EW, Álvarez C, Peigneur S, Tytgat J, Perdomo-Morales R. Panusin represents a new family of β-defensin- like peptides in invertebrates. Dev Comp Immunol. 2017 Feb;67:310-321. doi: 10.1016/j.dci.2016.09.002.
3. Pardo-Ruiz, Z., Menéndez-Sardiñas, D.E., Pacios-Michelena, A., Gabilondo-Ramírez, T., Montero-Alejo, V., Perdomo-Morales, R. Soluble β-(1,3)-glucans enhance LPS-induced response in the monocyte activation test, but inhibit LPS-mediated febrile response in rabbits: implications for pyrogenicity tests. European Journal of Pharmaceutical Sciences 81 (2016) 18–26.
4. Muñoz-Cernada, A., Pardo-Ruiz, Z., Cardentey, J., Montero-Alejo, V., Fernández- Cervera, M., García-Rodríguez, J., Amaro-González, D. Physicochemical and Biological Evaluation of Bioadhesive Polymers for the Development of Intranasal Low Sialic Acid Erythropoietin Formulations. BioProcessing Journal 13(1). 2014.
5. Muñoz-Cernada, A., Pardo-Ruiz, Z., Montero-Alejo, V., Fernández-Cervera, M., Sosa- Testé, I., García-Rodríguez, J. Effect of Nonionic Surfactants and HPMC F4M on the Development of Formulations of Neuro-EPO as a Neuroprotective Agent. Advanced Pharmaceutical Science and Technology (2014) 1(2).