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Items: 1 to 20 of 3158651

1.
Establishing a Quality Control System for Stem Cell-Based Medicinal Products in China
Bao-Zhu Yuan
Tissue Eng Part A. 2015 Dec 1; 21(23-24): 2783–2790. Published online 2015 Jan 28. doi: 10.1089/ten.tea.2014.0498
PMCID:
PMC4684656
AbstractArticlePDF–272K
2.
Evaluating and Reporting the Immunogenicity Impacts for Biological Products—a Clinical Pharmacology Perspective
Yow-Ming C. Wang, Jie Wang, Yuen Yi Hon, Lin Zhou, Lanyan Fang, Hae Young Ahn
AAPS J. 2016 Mar; 18(2): 395–403. Published online 2015 Dec 31. doi: 10.1208/s12248-015-9857-y
PMCID:
PMC4779104
AbstractArticlePDF–875K
3.
Removal of the innocuity test from The International Pharmacopoeia and WHO recommendations for vaccines and biological products
Dianliang Lei, Herbert Schmidt, Ivana Knezevic, Tiequn Zhou, Hye-na Kang, Sabine Kopp
Biologicals. 2020 Jul; 66: 17–20. doi: 10.1016/j.biologicals.2020.05.003
PMCID:
PMC7391003
AbstractArticle
4.
Rabies Control and Treatment: From Prophylaxis to Strategies with Curative Potential
Shimao Zhu, Caiping Guo
Viruses. 2016 Nov; 8(11): 279. Published online 2016 Oct 28. doi: 10.3390/v8110279
PMCID:
PMC5127009
AbstractArticlePDF–283K
5.
Report on the seventh meeting of national control laboratories for vaccines and biologicals of the WHO Western Pacific and South-East Asia member states
Sun Bo Shim, Chan Woong Choi, Jin Ho Shin, Jong Won Kim, Silke Schepelmann, Jae Ho Jung, Harish Chander, Ratih Pujilestari, Madoka Kuramitsu, Masaki Ochiai, Nee Yuan Qi, Geraldine N. Dimapilis, Luu Thi Dung, Hyung Sil Moon, In Soo Shin
Biologicals. 2023 Nov; 84: 101712. doi: 10.1016/j.biologicals.2023.101712
PMCID:
PMC10719889
AbstractArticle
6.
Outbreak of occupational Brucella infection caused by live attenuated Brucella vaccine in a biological products company in Chongqing, China, 2020
Chunbei Zhou, Wenli Huang, Xu Xiang, Jianping Qiu, Dayong Xiao, Ning Yao, Qiang Shu, Shuang Zhou
Emerg Microbes Infect. 2022; 11(1): 2544–2552. Published online 2022 Oct 26. doi: 10.1080/22221751.2022.2130099
PMCID:
PMC9621275
AbstractArticlePDF–1.4M
7.
Biological Products for the Treatment of Psoriasis: Therapeutic Targets, Pharmacodynamics and Disease-Drug-Drug Interaction Implications
Jie Wang, Yow-Ming C. Wang, Hae-Young Ahn
AAPS J. 2014 Sep; 16(5): 938–947. Published online 2014 Jul 4. doi: 10.1208/s12248-014-9637-0
PMCID:
PMC4147058
AbstractArticlePDF–297K
8.
Report of the AAPS Guidance Forum on the FDA Draft Guidance for Industry: “Drug Products, Including Biological Products, that Contain Nanomaterials”
Jon S. B. de Vlieger, Daan J. A. Crommelin, Katherine Tyner, Daryl C. Drummond, Wenlei Jiang, Scott E. McNeil, Sesha Neervannan, Rachael M. Crist, Vinod P. Shah
AAPS J. 2019 Jul; 21(4): 56. Published online 2019 Apr 17. doi: 10.1208/s12248-019-0329-7
PMCID:
PMC6470106
AbstractArticlePDF–608K
9.
Immunogenicity and safety of an enterovirus 71 vaccine in children aged 36-71 months: A double-blind, randomised, similar vaccine-controlled, non-inferiority phase III trial
Yeqing Tong, Xinyue Zhang, Jinhua Chen, Wei Chen, Zhao Wang, Qiong Li, Kai Duan, Sheng Wei, Beifang Yang, Xiaoai Qian, Jiahong Li, Lianju Hang, Shaoyong Deng, Xinguo Li, Changfu Guo, Heng Shen, Yan Liu, Peng Deng, Tingbo Xie, Qingliang Li, Li Li, Hongqiao Du, Qunying Mao, Fan Gao, Weiwei Lu, Xuhua Guan, Jiao Huang, Xiuling Li, Xiaoqi Chen
eClinicalMedicine. 2022 Oct; 52: 101596. Published online 2022 Jul 29. doi: 10.1016/j.eclinm.2022.101596
PMCID:
PMC9340505
AbstractArticlePDF–575K
10.
Research progress on circular RNA vaccines
Yu Bai, Dong Liu, Qian He, Jianyang Liu, Qunying Mao, Zhenglun Liang
Front Immunol. 2022; 13: 1091797. Published online 2023 Jan 12. doi: 10.3389/fimmu.2022.1091797
PMCID:
PMC9878156
AbstractArticlePDF–1.3M
11.
Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary
J Wang, T Johnson, L Sahin, MS Tassinari, PO Anderson, TE Baker, C Bucci-Rechtweg, GJ Burckart, CD Chambers, TW Hale, D Johnson-Lyles, RM Nelson, C Nguyen, D Pica-Branco, Z Ren, H Sachs, J Sauberan, A Zajicek, S Ito, LP Yao
Clin Pharmacol Ther. Author manuscript; available in PMC 2017 Sep 8.
Published in final edited form as: Clin Pharmacol Ther. 2017 Jun; 101(6): 736–744. doi: 10.1002/cpt.676
PMCID:
PMC5591026
AbstractArticlePDF–94K
12.
Versioning biological cells for trustworthy cell engineering
Jonathan Tellechea-Luzardo, Leanne Hobbs, Elena Velázquez, Lenka Pelechova, Simon Woods, Víctor de Lorenzo, Natalio Krasnogor
Nat Commun. 2022; 13: 765. Published online 2022 Feb 9. doi: 10.1038/s41467-022-28350-4
PMCID:
PMC8828774
AbstractArticlePDF–2.2M
13.
Biological and Chemical Diversity of Marine Sponge-Derived Microorganisms over the Last Two Decades from 1998 to 2017
Mei-Mei Cheng, Xu-Li Tang, Yan-Ting Sun, Dong-Yang Song, Yu-Jing Cheng, Hui Liu, Ping-Lin Li, Guo-Qiang Li
Molecules. 2020 Feb; 25(4): 853. Published online 2020 Feb 14. doi: 10.3390/molecules25040853
PMCID:
PMC7070270
AbstractArticlePDF–12M
14.
Comparability Considerations and Challenges for Expedited Development Programs for Biological Products
Sarah J. Schrieber, Wendy S. Putnam, Edwin Chiu Yuen Chow, Jacek Cieslak, Yanli Zhuang, Steven W. Martin, Paul Hanson, Frank Maggio, Leslie A. Rivera Rosado
Drugs R D. 2020 Dec; 20(4): 301–306. Published online 2020 Sep 10. doi: 10.1007/s40268-020-00321-4
PMCID:
PMC7691403
AbstractArticlePDF–825K
15.
Plant-based vaccines and antibodies to combat COVID-19: current status and prospects
Kuldeep Dhama, Senthilkumar Natesan, Mohd. Iqbal Yatoo, Shailesh Kumar Patel, Ruchi Tiwari, Shailendra K Saxena, Harapan Harapan
Hum Vaccin Immunother. 2020; 16(12): 2913–2920. Published online 2020 Dec 3. doi: 10.1080/21645515.2020.1842034
PMCID:
PMC7754927
AbstractArticlePDF–884K
16.
Astrocyte-targeted gene delivery of interleukin 2 specifically increases brain-resident regulatory T cell numbers and protects against pathological neuroinflammation
Lidia Yshii, Emanuela Pasciuto, Pascal Bielefeld, Loriana Mascali, Pierre Lemaitre, Marika Marino, James Dooley, Lubna Kouser, Stijn Verschoren, Vasiliki Lagou, Hannelore Kemps, Pascal Gervois, Antina de Boer, Oliver T. Burton, Jérôme Wahis, Jens Verhaert, Samar H. K. Tareen, Carlos P. Roca, Kailash Singh, Carly E. Whyte, Axelle Kerstens, Zsuzsanna Callaerts-Vegh, Suresh Poovathingal, Teresa Prezzemolo, Keimpe Wierda, Amy Dashwood, Junhua Xie, Elien Van Wonterghem, Eline Creemers, Meryem Aloulou, Willy Gsell, Oihane Abiega, Sebastian Munck, Roosmarijn E. Vandenbroucke, Annelies Bronckaers, Robin Lemmens, Bart De Strooper, Ludo Van Den Bosch, Uwe Himmelreich, Carlos P. Fitzsimons, Matthew G. Holt, Adrian Liston
Nat Immunol. 2022; 23(6): 878–891. Published online 2022 May 26. doi: 10.1038/s41590-022-01208-z
PMCID:
PMC9174055
AbstractArticlePDF–13M
17.
Advanced Methods for Natural Products Discovery: Bioactivity Screening, Dereplication, Metabolomics Profiling, Genomic Sequencing, Databases and Informatic Tools, and Structure Elucidation
Susana P. Gaudêncio, Engin Bayram, Lada Lukić Bilela, Mercedes Cueto, Ana R. Díaz-Marrero, Berat Z. Haznedaroglu, Carlos Jimenez, Manolis Mandalakis, Florbela Pereira, Fernando Reyes, Deniz Tasdemir
Mar Drugs. 2023 May; 21(5): 308. Published online 2023 May 19. doi: 10.3390/md21050308
PMCID:
PMC10222211
AbstractArticlePDF–7.4M
18.
A regulatory perspective of clinical trial applications for biological products with particular emphasis on Advanced Therapy Medicinal Products (ATMPs)
David R Jones, James W McBlane, Graham McNaughton, Nishanthan Rajakumaraswamy, Kirsty Wydenbach
Br J Clin Pharmacol. 2013 Aug; 76(2): 203–209. Published online 2012 Dec 6. doi: 10.1111/bcp.12057
PMCID:
PMC3731595
AbstractArticlePDF–624K
19.
Virome Characterization in Commercial Bovine Serum Batches—A Potentially Needed Testing Strategy for Biological Products
Willian P. Paim, Mayara F. Maggioli, Shollie M. Falkenberg, Akhilesh Ramachandran, Matheus N. Weber, Cláudio W. Canal, Fernando V. Bauermann
Viruses. 2021 Dec; 13(12): 2425. Published online 2021 Dec 3. doi: 10.3390/v13122425
PMCID:
PMC8705701
AbstractArticlePDF–1.4M
20.
Report of the third conference on next-generation sequencing for adventitious virus detection in biologics for humans and animals
Arifa S. Khan, Laurent Mallet, Johannes Blümel, Jean-Pol Cassart, Ivana Knezevic, Siemon H.S. Ng, Michael Wall, Miia Jakava-Viljanen, Carine Logvinoff, Ana Goios, Pieter Neels
Biologicals. 2023 Aug; 83: 101696. doi: 10.1016/j.biologicals.2023.101696
PMCID:
PMC10522920
AbstractArticle

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