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The role of Pharmacometrics in the development of Cuban Biotechnology products

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The role of Pharmacometrics in the development of Cuban Biotechnology products

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dc.contributor.author Rodríguez Vera, Leyanis
dc.contributor.author Mangas Sanjuan, Victor
dc.date.accessioned 2023-04-21T16:13:10Z
dc.date.available 2023-04-21T16:13:10Z
dc.date.issued 2020
dc.identifier.citation Rodríguez Vera, Leyanis Mangas Sanjuan, Víctor 2020 The role of Pharmacometrics in the development of Cuban Biotechnology products Biotecnologia Aplicada 37 4 4501 4507
dc.identifier.uri https://hdl.handle.net/10550/86147
dc.description.abstract Pharmacometrics is a vibrant scientific discipline that involves a cycle of excellence: integration, innovation and impact. This work was aimed to assess different pharmacometric approaches in three Cuban biotechnological products. A population pharmacokinetic analysis of nimotuzumab was performed in patients with stage III breast cancer with different doses of it, in combination with doxorubicin and cyclophosphamide. The pharmacokinetic/pharmacodynamic (PK/PD) characterization of Pegylated Recombinant Human Erythropoietin (rHuEPO) branched 32 kDa-PEG-rHuEPO and 40 kDa- PEG-rHuEPO was conducted and compared with reference products (ior®EPOCIM and MIRCERA®) in New Zealand rabbits. Data were analyzed using the nonlinear mixed-effect approach (NONMEM®). The best model for nimotuzumab was the Quasi Steady State approximation of the full Target Mediated Drug Disposition model that best described the linear and nonlinear PK. The recommended optimal biological dose ranged between 200-400mg/ week. On the other hand, a cell transit semi-mechanistic PK/PD model for characterizing rHuEPO profiles was obtained. The development of new branched PEG-chain formulations of rHuEPO improves its PK and PD properties, compared to those of commercially available formulations (i.e., ior®EPOCIM and MIRCERA®). Due to its integrative nature and predictive value, population modeling was very useful in the optimal characterization of the pharmacokinetic and pharmacodynamic properties of these three Cuban biotech drug products. It had a significant impact on decisionmaking by both the national regulatory agency and the local biopharmaceutical industry as to their research and development plans, as well as the subsequent marketing strategies for these new products, with substantial economic and time saving benefits. This work received the Annual Award of the Cuban Academy of Sciences for the year 2019.
dc.language.iso eng
dc.relation.ispartof Biotecnologia Aplicada, 2020, vol. 37, num. 4, p. 4501-4507
dc.subject Biotecnologia
dc.title The role of Pharmacometrics in the development of Cuban Biotechnology products
dc.type journal article
dc.date.updated 2023-04-21T16:13:10Z
dc.identifier.idgrec 157517
dc.rights.accessRights open access

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