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The growing role of biologics and biosimilars in the United States: Perspectives from the APhA Biologics and Biosimilars Stakeholder Conference

discipline specific-education (e.g., chemistry education, biology education, economics education)

[No authors listed]
GSID: _0w_GVv1NoYJ
J Crespi-Lofton, JB Skelton - Journal of the American Pharmacists …, 2017 - Elsevier

… drugs are generally produced through chemical synthesis, whereas biological products are … , and economic outcomes when implementing use management strategies (eg, formulary tiers, … -specific education, there was general agreement that education regarding all biological …

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Crespi-Lofton, J., & Skelton, J. B. (2017). The growing role of biologics and biosimilars in the United States: Perspectives from the APhA Biologics and Biosimilars Stakeholder Conference. Journal of the American Pharmacists Association, 57(5), e15-e27.
Crespi-Lofton, Judy, and Jann B. Skelton. "The growing role of biologics and biosimilars in the United States: Perspectives from the APhA Biologics and Biosimilars Stakeholder Conference." Journal of the American Pharmacists Association 57.5 (2017): e15-e27.
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Bacteriological and Molecular Detection of Streptococcus equi subsp. equi and Streptococcus equi subsp. zooepidemicus in Equines of Northern India.

Journal of equine science

Mir IA, Kumar B, Taku A, Faridi F, Bhat MA, Baba NA, Maqbool T.
PMID: 24834002
J Equine Sci. 2013;24(3):53-5. doi: 10.1294/jes.24.53. Epub 2013 Sep 30.

Present study was undertaken to study the prevalence of β-haemolytic streptococci in equine of northern temperate region of Jammu and Kashmir, India. One hundred and forty one samples were collected in duplicate from nasopharyngeal tract of diseased (53) and...

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Mir IA, Kumar B, Taku A, et al. Bacteriological and Molecular Detection of Streptococcus equi subsp. equi and Streptococcus equi subsp. zooepidemicus in Equines of Northern India. J Equine Sci. 2013;24(3):53-5doi: 10.1294/jes.24.53.
Mir, I. A., Kumar, B., Taku, A., Faridi, F., Bhat, M. A., Baba, N. A., & Maqbool, T. (2013). Bacteriological and Molecular Detection of Streptococcus equi subsp. equi and Streptococcus equi subsp. zooepidemicus in Equines of Northern India. Journal of equine science, 24(3), 53-5. https://doi.org/10.1294/jes.24.53
Mir, Irfan Ahmad, et al. "Bacteriological and Molecular Detection of Streptococcus equi subsp. equi and Streptococcus equi subsp. zooepidemicus in Equines of Northern India." Journal of equine science vol. 24,3 (2013): 53-5. doi: https://doi.org/10.1294/jes.24.53
Mir IA, Kumar B, Taku A, Faridi F, Bhat MA, Baba NA, Maqbool T. Bacteriological and Molecular Detection of Streptococcus equi subsp. equi and Streptococcus equi subsp. zooepidemicus in Equines of Northern India. J Equine Sci. 2013;24(3):53-5. doi: 10.1294/jes.24.53. Epub 2013 Sep 30. PMID: 24834002; PMCID: PMC4013984.
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Comparison of the Protective Efficacy of Neutralizing Epitopes of 2009 Pandemic H1N1 Influenza Hemagglutinin.

Frontiers in immunology

Peng B, Peng N, Zhang Y, Zhang F, Li X, Chang H, Fang F, Wang F, Lu F, Chen Z.
PMID: 28912784
Front Immunol. 2017 Aug 31;8:1070. doi: 10.3389/fimmu.2017.01070. eCollection 2017.

The 2009 H1N1 influenza (Pdm09) pandemic has been referred to as the first influenza pandemic of the twenty-first century. There is a marked difference in antigenicity between the pandemic H1N1 virus and past seasonal H1N1 viruses, which allowed the...

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Peng B, Peng N, Zhang Y, et al. Comparison of the Protective Efficacy of Neutralizing Epitopes of 2009 Pandemic H1N1 Influenza Hemagglutinin. Front Immunol. 2017;8:1070doi: 10.3389/fimmu.2017.01070.
Peng, B., Peng, N., Zhang, Y., Zhang, F., Li, X., Chang, H., Fang, F., Wang, F., Lu, F., & Chen, Z. (2017). Comparison of the Protective Efficacy of Neutralizing Epitopes of 2009 Pandemic H1N1 Influenza Hemagglutinin. Frontiers in immunology, 81070. https://doi.org/10.3389/fimmu.2017.01070
Peng, Bo, et al. "Comparison of the Protective Efficacy of Neutralizing Epitopes of 2009 Pandemic H1N1 Influenza Hemagglutinin." Frontiers in immunology vol. 8 (2017): 1070. doi: https://doi.org/10.3389/fimmu.2017.01070
Peng B, Peng N, Zhang Y, Zhang F, Li X, Chang H, Fang F, Wang F, Lu F, Chen Z. Comparison of the Protective Efficacy of Neutralizing Epitopes of 2009 Pandemic H1N1 Influenza Hemagglutinin. Front Immunol. 2017 Aug 31;8:1070. doi: 10.3389/fimmu.2017.01070. eCollection 2017. PMID: 28912784; PMCID: PMC5583165.
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Adapting viral safety assurance strategies to continuous processing of biological products.

Biotechnology and bioengineering

Johnson SA, Brown MR, Lute SC, Brorson KA.
PMID: 28425635
Biotechnol Bioeng. 2017 Jun;114(6):1362. doi: 10.1002/bit.26245.

No abstract available.

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Johnson SA, Brown MR, Lute SC, et al. Adapting viral safety assurance strategies to continuous processing of biological products. Biotechnol Bioeng. 2017;114(6):1362doi: 10.1002/bit.26245.
Johnson, S. A., Brown, M. R., Lute, S. C., & Brorson, K. A. (2017). Adapting viral safety assurance strategies to continuous processing of biological products. Biotechnology and bioengineering, 114(6), 1362. https://doi.org/10.1002/bit.26245
Johnson, Sarah A, et al. "Adapting viral safety assurance strategies to continuous processing of biological products." Biotechnology and bioengineering vol. 114,6 (2017): 1362. doi: https://doi.org/10.1002/bit.26245
Johnson SA, Brown MR, Lute SC, Brorson KA. Adapting viral safety assurance strategies to continuous processing of biological products. Biotechnol Bioeng. 2017 Jun;114(6):1362. doi: 10.1002/bit.26245. PMID: 28425635.
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Mg(OMe).

Organic & biomolecular chemistry

Lai L, Li AN, Zhou J, Guo Y, Lin L, Chen W, Wang R.
PMID: 28220169
Org Biomol Chem. 2017 Mar 08;15(10):2185-2190. doi: 10.1039/c7ob00131b.

This work concerns the Mg(OMe)

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Lai L, Li AN, Zhou J, et al. Mg(OMe). Org Biomol Chem. 2017;15(10):2185-2190doi: 10.1039/c7ob00131b.
Lai, L., Li, A. N., Zhou, J., Guo, Y., Lin, L., Chen, W., & Wang, R. (2017). Mg(OMe). Organic & biomolecular chemistry, 15(10), 2185-2190. https://doi.org/10.1039/c7ob00131b
Lai, Luhao, et al. "Mg(OMe)." Organic & biomolecular chemistry vol. 15,10 (2017): 2185-2190. doi: https://doi.org/10.1039/c7ob00131b
Lai L, Li AN, Zhou J, Guo Y, Lin L, Chen W, Wang R. Mg(OMe). Org Biomol Chem. 2017 Mar 08;15(10):2185-2190. doi: 10.1039/c7ob00131b. PMID: 28220169.
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Dynamic urinary proteomic analysis reveals stable proteins to be potential biomarkers.

Proteomics. Clinical applications

Sun W, Chen Y, Li F, Zhang L, Yang R, Zhang Z, Zheng D, Gao Y.
PMID: 26238754
Proteomics Clin Appl. 2009 Mar;3(3):370-82. doi: 10.1002/prca.200800061.

Human urinary proteome analysis is a convenient and efficient approach for understanding disease processes affecting the kidney and urogenital tract. Many potential biomarkers have been identified in previous differential analyses; however, dynamic variations of the urinary proteome have not...

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Sun W, Chen Y, Li F, et al. Dynamic urinary proteomic analysis reveals stable proteins to be potential biomarkers. Proteomics Clin Appl. 2009;3(3):370-82doi: 10.1002/prca.200800061.
Sun, W., Chen, Y., Li, F., Zhang, L., Yang, R., Zhang, Z., Zheng, D., & Gao, Y. (2009). Dynamic urinary proteomic analysis reveals stable proteins to be potential biomarkers. Proteomics. Clinical applications, 3(3), 370-82. https://doi.org/10.1002/prca.200800061
Sun, Wei, et al. "Dynamic urinary proteomic analysis reveals stable proteins to be potential biomarkers." Proteomics. Clinical applications vol. 3,3 (2009): 370-82. doi: https://doi.org/10.1002/prca.200800061
Sun W, Chen Y, Li F, Zhang L, Yang R, Zhang Z, Zheng D, Gao Y. Dynamic urinary proteomic analysis reveals stable proteins to be potential biomarkers. Proteomics Clin Appl. 2009 Mar;3(3):370-82. doi: 10.1002/prca.200800061. PMID: 26238754.
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Development of a PCR assay to detect mycoplasma contamination in cord blood hematopoietic stem cells.

Iranian journal of microbiology

Tabatabaei-Qomi R, Sheykh-Hasan M, Fazaely H, Kalhor N, Ghiasi M.
PMID: 25802713
Iran J Microbiol. 2014 Aug;6(4):281-4.

BACKGROUND AND OBJECTIVES: Contamination of cell lines and biological products is one of the major problems of cell culture techniques. Rapid detection of mycoplasma contamination in cell culture is an important part of quality control standards in related laboratories....

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Tabatabaei-Qomi R, Sheykh-Hasan M, Fazaely H, et al. Development of a PCR assay to detect mycoplasma contamination in cord blood hematopoietic stem cells. Iran J Microbiol. 2014;6(4):281-4
Tabatabaei-Qomi, R., Sheykh-Hasan, M., Fazaely, H., Kalhor, N., & Ghiasi, M. (2014). Development of a PCR assay to detect mycoplasma contamination in cord blood hematopoietic stem cells. Iranian journal of microbiology, 6(4), 281-4.
Tabatabaei-Qomi, Reza, et al. "Development of a PCR assay to detect mycoplasma contamination in cord blood hematopoietic stem cells." Iranian journal of microbiology vol. 6,4 (2014): 281-4.
Tabatabaei-Qomi R, Sheykh-Hasan M, Fazaely H, Kalhor N, Ghiasi M. Development of a PCR assay to detect mycoplasma contamination in cord blood hematopoietic stem cells. Iran J Microbiol. 2014 Aug;6(4):281-4. PMID: 25802713; PMCID: PMC4367946.
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Screening for Anti-Cancer Compounds in Marine Organisms in Oman.

Sultan Qaboos University medical journal

Dobretsov S, Tamimi Y, Al-Kindi MA, Burney I.
PMID: 27226907
Sultan Qaboos Univ Med J. 2016 May;16(2):e168-74. doi: 10.18295/squmj.2016.16.02.006. Epub 2016 May 15.

OBJECTIVES: Marine organisms are a rich source of bioactive molecules with potential applications in medicine, biotechnology and industry; however, few bioactive compounds have been isolated from organisms inhabiting the Arabian Gulf and the Gulf of Oman. This study aimed...

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Dobretsov S, Tamimi Y, Al-Kindi MA, et al. Screening for Anti-Cancer Compounds in Marine Organisms in Oman. Sultan Qaboos Univ Med J. 2016;16(2):e168-74doi: 10.18295/squmj.2016.16.02.006.
Dobretsov, S., Tamimi, Y., Al-Kindi, M. A., & Burney, I. (2016). Screening for Anti-Cancer Compounds in Marine Organisms in Oman. Sultan Qaboos University medical journal, 16(2), e168-74. https://doi.org/10.18295/squmj.2016.16.02.006
Dobretsov, Sergey, et al. "Screening for Anti-Cancer Compounds in Marine Organisms in Oman." Sultan Qaboos University medical journal vol. 16,2 (2016): e168-74. doi: https://doi.org/10.18295/squmj.2016.16.02.006
Dobretsov S, Tamimi Y, Al-Kindi MA, Burney I. Screening for Anti-Cancer Compounds in Marine Organisms in Oman. Sultan Qaboos Univ Med J. 2016 May;16(2):e168-74. doi: 10.18295/squmj.2016.16.02.006. Epub 2016 May 15. PMID: 27226907; PMCID: PMC4868515.
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Complete Genome Sequence of Foot-and-Mouth Disease Virus Serotype O Strain YNTBa from Yunnan Province of China.

Genome announcements

Yan H, Wang J, Zhu M, Miao H, Peng Z, Li H, Xin A.
PMID: 28572308
Genome Announc. 2017 Jun 01;5(22). doi: 10.1128/genomeA.00393-17.

YNTBa is a rabbit-passaged attenuated strain of foot-and-mouth disease virus (FMDV) serotype O. Here, we announce the complete genome sequence of YNTBa, which provides data for further studies on replication, virulence, its determinants, and cell and host tropism of...

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Yan H, Wang J, Zhu M, et al. Complete Genome Sequence of Foot-and-Mouth Disease Virus Serotype O Strain YNTBa from Yunnan Province of China. Genome Announc. 2017;5(22)doi: 10.1128/genomeA.00393-17.
Yan, H., Wang, J., Zhu, M., Miao, H., Peng, Z., Li, H., & Xin, A. (2017). Complete Genome Sequence of Foot-and-Mouth Disease Virus Serotype O Strain YNTBa from Yunnan Province of China. Genome announcements, 5(22), . https://doi.org/10.1128/genomeA.00393-17
Yan, Huan, et al. "Complete Genome Sequence of Foot-and-Mouth Disease Virus Serotype O Strain YNTBa from Yunnan Province of China." Genome announcements vol. 5,22 (2017). doi: https://doi.org/10.1128/genomeA.00393-17
Yan H, Wang J, Zhu M, Miao H, Peng Z, Li H, Xin A. Complete Genome Sequence of Foot-and-Mouth Disease Virus Serotype O Strain YNTBa from Yunnan Province of China. Genome Announc. 2017 Jun 01;5(22). doi: 10.1128/genomeA.00393-17. PMID: 28572308; PMCID: PMC5454191.
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Regulatory science accelerates the development of biotechnology drugs and vaccines by NIFDC.

Emerging microbes & infections

Liang Z, Mao Q, Wang Y, Li C, Gao K, Wang J.
PMID: 26038758
Emerg Microbes Infect. 2014 Sep;3(9):e67. doi: 10.1038/emi.2014.66. Epub 2014 Sep 17.

The Chinese National Institutes for Food and Drug Control (NIFDC) is the national laboratory responsible for the quality control of pharmaceutical products. In recent years, to ensure the quality of biological products and improve the research and development (R&D)...

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Liang Z, Mao Q, Wang Y, et al. Regulatory science accelerates the development of biotechnology drugs and vaccines by NIFDC. Emerg Microbes Infect. 2014;3(9):e67doi: 10.1038/emi.2014.66.
Liang, Z., Mao, Q., Wang, Y., Li, C., Gao, K., & Wang, J. (2014). Regulatory science accelerates the development of biotechnology drugs and vaccines by NIFDC. Emerging microbes & infections, 3(9), e67. https://doi.org/10.1038/emi.2014.66
Liang, Zhenglun, et al. "Regulatory science accelerates the development of biotechnology drugs and vaccines by NIFDC." Emerging microbes & infections vol. 3,9 (2014): e67. doi: https://doi.org/10.1038/emi.2014.66
Liang Z, Mao Q, Wang Y, Li C, Gao K, Wang J. Regulatory science accelerates the development of biotechnology drugs and vaccines by NIFDC. Emerg Microbes Infect. 2014 Sep;3(9):e67. doi: 10.1038/emi.2014.66. Epub 2014 Sep 17. PMID: 26038758; PMCID: PMC4185363.
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A Multicenter Study To Evaluate the Performance of High-Throughput Sequencing for Virus Detection.

mSphere

Khan AS, Ng SHS, Vandeputte O, Aljanahi A, Deyati A, Cassart JP, Charlebois RL, Taliaferro LP.
PMID: 28932815
mSphere. 2017 Sep 13;2(5). doi: 10.1128/mSphere.00307-17. eCollection 2017.

The capability of high-throughput sequencing (HTS) for detection of known and unknown viruses makes it a powerful tool for broad microbial investigations, such as evaluation of novel cell substrates that may be used for the development of new biological...

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Khan AS, Ng SHS, Vandeputte O, et al. A Multicenter Study To Evaluate the Performance of High-Throughput Sequencing for Virus Detection. mSphere. 2017;2(5)doi: 10.1128/mSphere.00307-17.
Khan, A. S., Ng, S. H. S., Vandeputte, O., Aljanahi, A., Deyati, A., Cassart, J. P., Charlebois, R. L., & Taliaferro, L. P. (2017). A Multicenter Study To Evaluate the Performance of High-Throughput Sequencing for Virus Detection. mSphere, 2(5), . https://doi.org/10.1128/mSphere.00307-17
Khan, Arifa S, et al. "A Multicenter Study To Evaluate the Performance of High-Throughput Sequencing for Virus Detection." mSphere vol. 2,5 (2017). doi: https://doi.org/10.1128/mSphere.00307-17
Khan AS, Ng SHS, Vandeputte O, Aljanahi A, Deyati A, Cassart JP, Charlebois RL, Taliaferro LP. A Multicenter Study To Evaluate the Performance of High-Throughput Sequencing for Virus Detection. mSphere. 2017 Sep 13;2(5). doi: 10.1128/mSphere.00307-17. eCollection 2017. PMID: 28932815; PMCID: PMC5597969.
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Immunological analysis of aerobic bioreactor bovine theileriosis vaccine.

Iranian journal of parasitology

Habibi G, Esmaeil-Nia K, Izadi H, Ataie Amarloie O, Afshari A, Bordbar N.
PMID: 25678923
Iran J Parasitol. 2014 Sep;9(3):382-93.

BACKGROUND: In this study, the pilot production of aerobic bioreactor tropical theileriosis vaccine was optimized with the aim of immunological assays for further mass production.METHODS: We have shown earlier the delayed type hypersensitivity (DTH) assay could be used for...

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Habibi G, Esmaeil-Nia K, Izadi H, et al. Immunological analysis of aerobic bioreactor bovine theileriosis vaccine. Iran J Parasitol. 2014;9(3):382-93
Habibi, G., Esmaeil-Nia, K., Izadi, H., Ataie Amarloie, O., Afshari, A., & Bordbar, N. (2014). Immunological analysis of aerobic bioreactor bovine theileriosis vaccine. Iranian journal of parasitology, 9(3), 382-93.
Habibi, Gholamreza, et al. "Immunological analysis of aerobic bioreactor bovine theileriosis vaccine." Iranian journal of parasitology vol. 9,3 (2014): 382-93.
Habibi G, Esmaeil-Nia K, Izadi H, Ataie Amarloie O, Afshari A, Bordbar N. Immunological analysis of aerobic bioreactor bovine theileriosis vaccine. Iran J Parasitol. 2014 Sep;9(3):382-93. PMID: 25678923; PMCID: PMC4316570.
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Showing 1 to 12 of 550 entries