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| Mendoza-Macedo,Karina; Romero-Díaz,Alexis J; Miranda-Hernández,Mariana P; Campos-García,Víctor R; Ramírez-Ibañez,Nancy D; Juárez-Bayardo,L. Carmina; Moreno-Duran,Karen; Cedillo-Robles,Miriam S; Pérez,Nestor O; Jung-Cook,Helgi; Flores-Ortiz,Luis F; Medina-Rivero,Emilio. |
| Background: Developing countries have an estimate of ten times more approved biosimilars than developed countries. This disparity demands the need of an objective regulation that incorporates health policies according to the technological and economical capabilities of each country. One of the challenges lies on the establishment of comparability principles based on a physicochemical and biological characterization that should determine the extent of additional non-clinical and clinical studies. This is particularly relevant for licensed biosimilars in developing countries, which have an extensive clinical experience since their approval as generics' in some cases more than a decade. To exemplify the current status of biosimilars in Mexico' a... |
| Tipo: Journal article |
Palavras-chave: Bio therapeutic; Comparability; Critical quality attributes; Developing countries; Generics; Health policies; High quality biosimilars; Regulation. |
| Ano: 2016 |
URL: http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-34582016000600010 |
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| Weiner, Agnes K. M.; Morard, Raphael; Weinkauf, Manuel F. G.; Darling, Kate F.; André, Aurore; Quillévéré, Frédéric; Ujiie, Yurika; Douady, Christophe J.; De Vargas, Colomban; Kucera, Michal. |
| Single-cell genetic analysis is an essential method to investigate the biodiversity and evolutionary ecology of marine protists. In protist groups that do not reproduce under laboratory conditions, this approach provides the only means to directly associate molecular sequences with cell morphology. The resulting unambiguous taxonomic identification of the DNA sequences is a prerequisite for barcoding and analyses of environmental metagenomic data. Extensive single-cell genetic studies have been carried out on planktonic foraminifera over the past 20 years to elucidate their phylogeny, cryptic diversity, biogeography, and the relationship between genetic and morphological variability. In the course of these investigations, it has become evident that genetic... |
| Tipo: Text |
Palavras-chave: Foraminifera; Protists; Single-cell genetics; Cryptic diversity; Comparability; Methods; Laboratory protocols; Standardization. |
| Ano: 2016 |
URL: https://archimer.ifremer.fr/doc/00383/49460/49938.pdf |
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| Hao, Jun; Liu, Jie. |
| On the basis of introducing relevant theories of Engel’s coefficient, this paper analyzes the limitation of these theories in practical application currently in China, for example, continuing to use original theory, not in line with reality of China; comparison invalidity in length and breadth, is not conducive to relevant analysis; culling out the special factors easily causes distortion of conclusion. Taking rural areas in Hebei Province as an example, this paper analyzes the limitation of Engel’s coefficient in analyzing the gap of rural economy: in terms of region horizontally, Engel’s coefficient neglects the difference of consumption structure among regions, and difference of economic stages among regions; in terms of time vertically, Engel’s... |
| Tipo: Journal Article |
Palavras-chave: Engel’s coefficient; Difference of consumption structure; Economic cycle; Comparability; Rural areas in Hebei Province; China; Agribusiness. |
| Ano: 2011 |
URL: http://purl.umn.edu/113476 |
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