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在“Elsevier电子期刊”中，命中：26条，耗时：0.0329848 秒

在所有数据库中总计命中：100条

1.Characterization and comparability of biosimilars: A filgrastim case of study and regulatory perspectives for Latin America

作者：Karina Mendoza-Macedo^a ; Alexis J. Romero-Dí ; az^b ; Mariana P. Miranda-Herná ; ndez^b ; Ví ; ctor R. Campos-Garcí ; a^b ; Nancy D. Ramí ; rez-Ibañ ; ez^b ; L. Carmina Juá ; rez-Bayardo^b ; Karen Moreno-Duran^b ; Miriam S. Cedillo-Robles^c ; Nestor O. Pé ; rez^b ; Helgi Jung-Cook^a ; Luis F. Flores-Ortiz^b ; ^{luis.flores@probiomed.com.mx" class="auth_mail" title="E-mail the corresponding author} ; Emilio Medina-Rivero^b ; ^{emilio.medina@probiomed.com.mx" class="auth_mail" title="E-mail the corresponding author}

关键词：Bio therapeutic ; Comparability ; Critical quality attributes ; Developing countries ; Generics ; Health policies ; High quality biosimilars ; Regulation

刊名：Electronic Journal of Biotechnology

出版年：2016

2.Advancing pharmaceutical quality: An overview of science and research in the U.S. FDA’s Office of Pharmaceutical Quality

作者：Adam C. Fisher^a ; Sau L. Lee^a ; ^{sau.lee@fda.hhs.gov} ; Daniel P. Harris^a ; Lucinda Buhse^a ; Steven Kozlowski^a ; Lawrence Yu^a ; Michael Kopcha^a ; Janet Woodcock^b

关键词：ADF ; abuse deterrent formulation ; API ; active pharmaceutical ingredient ; T-DM1 ; Ado-Trastuzumab Emtansine ; ADC ; antibody-drug conjugate ; CDER ; center for drug evaluation and research ; CBRN/EID ; chemical ; biological ; radiological/nuclear and emerging infectious disease ; CMC ; chemistry ; manufacturing ; and controls ; DMD ; Duchenne muscular dystrophy ; DLS ; dynamic light scattering ; FDA ; food and drug administration ; FTIR ; Fourier transform infrared spectroscopy ; GA ; glatiramer acetate ; IVIVC ; in vivo

刊名：International Journal of Pharmaceutics

出版年：2016

作者：Majed Khraishi ; MB ; BCh ; FRCPC¹ ; ^{mkhraishi@gmail.com" class="auth_mail" title="E-mail the corresponding author} ; ^{mkhraishi@nexusresearch.com" class="auth_mail" title="E-mail the corresponding author} ; David Stead ; GPhC ; MRPharmS ; DMS² ; Milan Lukas ; MD ; PhD³ ; Florian Scotte ; MD ; PhD⁴ ; Holger Schmid ; MD ; MSc⁵

刊名：Clinical Therapeutics

出版年：2016

4.Development of biosimilars

作者：Ahmad AL-Sabbagh ; MD^a ; Ewa Olech ; MD^b ; ^{eolech@unr.edu" class="auth_mail" title="E-mail the corresponding author} ; ^{ewaolech@yahoo.com" class="auth_mail" title="E-mail the corresponding author} ; Joseph E. McClellan ; PhD ; MBA^c ; Carol F. Kirchhoff ; PhD^d

关键词：Biologic ; Biosimilar ; Biosimilarity ; Characterization ; Chronic inflammatory diseases ; Clinical ; Comparability ; Development ; Functional ; Immunogenicity ; Innovator ; Manufacturing ; Pharmacodynamics ; Pharmacokinetics ; Preclinical ; Quality ; Reference product ; Regulatory requirements ; Safety ; Structural

刊名：Seminars in Arthritis and Rheumatism

出版年：2016

5.Assessing analytical comparability of biosimilars: GCSF as a case study

作者：Neh Nupur ; Sumit Kumar Singh ; Gunjan Narula ; Anurag S. Rathore ; ¹ ; ^{asrathore@biotechcmz.com" class="auth_mail" title="E-mail the corresponding author}

关键词：CQA ; critical quality attributes ; GCSF ; granulocyte colony stimulating factor ; CD ; circular dichroism spectroscopy ; RPC ; reverse phase chromatography ; SEC ; size exclusion chromatography ; FLD ; fluorescence detector ; mAbs ; monoclonal antibodies ; PTM ; post translational modification ; ICH ; International Conference on Harmonisation ; CID ; collision induced dissociation ; ETD ; electron transfer dissociation ; HSQC NMR ; heteronuclear single quantum coherence nuclear magnetic resonance spectroscopy ; CDSCO

刊名：Journal of Chromatography B, Analytical Technologies in the Biomedical and Life Sciences

出版年：2016

作者：Ewa Olech ; MD ^{eolech@unr.edu" class="auth_mail" title="E-mail the corresponding author} ^{ewaolech@yahoo.com" class="auth_mail" title="E-mail the corresponding author}

刊名：Seminars in Arthritis and Rheumatism

出版年：2016

7.Understanding the biosimilar approval and extrapolation process—A case study of an epoetin biosimilar

作者：Amit B. Agarwal^a ; ^{aagarwal@uacc.arizona.edu" class="auth_mail" title="E-mail the corresponding author}Author Vitae ; Ali McBride^b ; ^{alimcbride@gmail.com" class="auth_mail" title="E-mail the corresponding author}Author Vitae

刊名：Critical Reviews in Oncology and Hematology

出版年：2016

8.Cost-effectiveness Analysis of Treatment Sequence Initiating With Etanercept Compared With Leflunomide in Rheumatoid Arthritis: Impact of Reduced Etanercept Cost With Patent Expiration in South Korea

作者：Sun-Kyeong Park ; B.S.¹ ; ^* ; Seung-Hoo Park ; B.S.¹ ; ^* ; Min-Young Lee ; Ph.D.¹ ; Ji-Hyun Park ; MS¹ ; ² ; Jae-Hong Jeong² ; Eui-Kyung Lee¹ ; ^{ekyung@skku.edu" class="auth_mail" title="E-mail the corresponding author}

关键词：cost-effectiveness ; early biologics use ; etanercept ; reduced price ; rheumatoid arthritis

刊名：Clinical Therapeutics

出版年：2016

9.Treating to target in established rheumatoid arthritis: Challenges and opportunities in an era of novel targeted therapies and biosimilars

作者：Thasia G. Woodworth ; MD^a ; ^{thasia@woodworth.info" class="auth_mail" title="E-mail the corresponding author} (Visiting Clinical Research Scientist) ; Alfons A. den Broeder^b

关键词：Rheumatoid arthritis ; Treat-to-target ; Disease activity ; Remission ; Disease modifying antirheumatic drugs ; Biologics and biosimilars

刊名：Best Practice Research Clinical Rheumatology

出版年：2015

10.Key considerations in the preclinical development of biosimilars

作者：Lynne A. Bui¹ ; ^{lbui@gcrioncology.com" class="auth_mail" title="E-mail the corresponding author} ; Susan Hurst² ; Gregory L. Finch³ ; Beverly Ingram⁴ ; Ira A. Jacobs⁵ ; Carol F. Kirchhoff⁶ ; Chee-Keng Ng⁴ ; Anne M. Ryan³

刊名：Drug Discovery Today

出版年：2015

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