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Items: 1 to 20 of 281

1.

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

Agarwal AB, McBride A.

Crit Rev Oncol Hematol. 2016 Aug;104:98-107. doi: 10.1016/j.critrevonc.2016.04.016. Epub 2016 May 20. Review.

PMID:
27317353
2.

Evaluation of the structural, physicochemical, and biological characteristics of SB4, a biosimilar of etanercept.

Cho IH, Lee N, Song D, Jung SY, Bou-Assaf G, Sosic Z, Zhang W, Lyubarskaya Y.

MAbs. 2016 Aug-Sep;8(6):1136-55. doi: 10.1080/19420862.2016.1193659. Epub 2016 May 31.

3.

Nanomaterials in the aquatic environment: A European Union-United States perspective on the status of ecotoxicity testing, research priorities, and challenges ahead.

Selck H, Handy RD, Fernandes TF, Klaine SJ, Petersen EJ.

Environ Toxicol Chem. 2016 May;35(5):1055-67. doi: 10.1002/etc.3385.

PMID:
27089437
4.

Japanese regulation of biosimilar products: past experience and current challenges.

Arato T.

Br J Clin Pharmacol. 2016 Jul;82(1):30-40. doi: 10.1111/bcp.12931. Epub 2016 Apr 27. Review.

PMID:
26987746
5.

A phase I pharmacokinetics study comparing PF-06439535 (a potential biosimilar) with bevacizumab in healthy male volunteers.

Knight B, Rassam D, Liao S, Ewesuedo R.

Cancer Chemother Pharmacol. 2016 Apr;77(4):839-46. doi: 10.1007/s00280-016-3001-2. Epub 2016 Mar 16.

6.

Proteomics for the authentication of fish species.

Mazzeo MF, Siciliano RA.

J Proteomics. 2016 Mar 4. pii: S1874-3919(16)30064-1. doi: 10.1016/j.jprot.2016.03.007. [Epub ahead of print]

PMID:
26947551
7.

Rabies in the Baltic States: Decoding a Process of Control and Elimination.

Robardet E, Picard-Meyer E, Dobroštana M, Jaceviciene I, Mähar K, Muižniece Z, Pridotkas G, Masiulis M, Niin E, Olševskis E, Cliquet F.

PLoS Negl Trop Dis. 2016 Feb 5;10(2):e0004432. doi: 10.1371/journal.pntd.0004432. eCollection 2016 Feb. Review.

8.

Biosimilars: A consideration of the regulations in the United States and European union.

Daller J.

Regul Toxicol Pharmacol. 2016 Apr;76:199-208. doi: 10.1016/j.yrtph.2015.12.013. Epub 2015 Dec 28.

PMID:
26732800
9.

HOW DO WE EVALUATE AND MANAGE MANY DIFFERENT VACCINATION SCHEDULES IN THE EU?

Vladimir O, Zuzana K, Štefkovičová M.

Cent Eur J Public Health. 2015 Sep;23(3):218-22. Review.

10.

Kava for the treatment of generalised anxiety disorder (K-GAD): study protocol for a randomised controlled trial.

Savage KM, Stough CK, Byrne GJ, Scholey A, Bousman C, Murphy J, Macdonald P, Suo C, Hughes M, Thomas S, Teschke R, Xing C, Sarris J.

Trials. 2015 Nov 2;16:493. doi: 10.1186/s13063-015-0986-5.

11.

How to use mechanistic effect models in environmental risk assessment of pesticides: Case studies and recommendations from the SETAC workshop MODELINK.

Hommen U, Forbes V, Grimm V, Preuss TG, Thorbek P, Ducrot V.

Integr Environ Assess Manag. 2016 Jan;12(1):21-31. doi: 10.1002/ieam.1704. Epub 2015 Oct 29.

PMID:
26437629
12.

Manufacturing of Plasma-Derived Medicinal Products: Qualification Process of Plasma Suppliers.

Parés C, Martínez M, Messeguer J, Rodríguez E.

PDA J Pharm Sci Technol. 2015 Sep-Oct;69(5):620-30. doi: 10.5731/pdajpst.2015.01074.

PMID:
26429109
14.

Biosimilar monoclonal antibodies: the scientific basis for extrapolation.

Schellekens H, Lietzan E, Faccin F, Venema J.

Expert Opin Biol Ther. 2015;15(11):1633-46. doi: 10.1517/14712598.2015.1083552. Epub 2015 Sep 12. Review.

PMID:
26365396
15.

[Biosimilars versus original biologics. Similarities and differences from development to approval].

Windisch J.

Z Rheumatol. 2015 Oct;74(8):672-81. doi: 10.1007/s00393-014-1486-9. German.

PMID:
26323591
16.

Biosimilar regulation in the EU.

Kurki P, Ekman N.

Expert Rev Clin Pharmacol. 2015;8(5):649-59. doi: 10.1586/17512433.2015.1071188. Review.

PMID:
26294076
17.

Draft Genome Sequences of Klebsiella oxytoca Isolates Originating from a Highly Contaminated Liquid Hand Soap Product.

Hammerl JA, Lasch P, Nitsche A, Dabrowski PW, Hahmann H, Wicke A, Kleta S, Al Dahouk S, Dieckmann R.

Genome Announc. 2015 Jul 23;3(4). pii: e00820-15. doi: 10.1128/genomeA.00820-15.

18.

Drug safety aspects of herbal medicinal products.

Wegener T, Deitelhoff B, Silber-Mankowsky A.

Wien Med Wochenschr. 2015 Jun;165(11-12):243-50. doi: 10.1007/s10354-015-0370-9. Epub 2015 Jul 17.

PMID:
26183727
19.

Virgin olive oil: a key food for cardiovascular risk protection.

Covas MI, de la Torre R, Fitó M.

Br J Nutr. 2015 Apr;113 Suppl 2:S19-28. doi: 10.1017/S0007114515000136. Review.

PMID:
26148918
20.

Efficacy of Grass Pollen Allergen Sublingual Immunotherapy Tablets for Seasonal Allergic Rhinoconjunctivitis: A Systematic Review and Meta-analysis.

Di Bona D, Plaia A, Leto-Barone MS, La Piana S, Di Lorenzo G.

JAMA Intern Med. 2015 Aug;175(8):1301-9. doi: 10.1001/jamainternmed.2015.2840. Review.

PMID:
26120825
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