Physicochemical, biological, functional and toxicological characterization of the European follow-on glatiramer acetate product as compared with Copaxone

Author:

Melamed-Gal S.,Loupe P.,Timan B.,Weinstein V.,Kolitz S.,Zhang J.,Funt J.,Komlosh A.,Ashkenazi N.,Bar-Ilan O.,Konya A.,Beriozkin O.,Laifenfeld D.,Hasson T.,Krispin R.,Molotsky T.,Papir G.,Sulimani L.,Zeskind B.,Liu P.,Nock S.,Hayden M.R.,Gilbert A.,Grossman I.

Publisher

Elsevier BV

Subject

Neurology

Reference34 articles.

1. Non-Biological Complex Drugs. The Science and the Regulatory Landscape;Weinstein,2015

2. Design of a strong cation exchange methodology for the evaluation of charge heterogeneity in glatiramer acetate;Campos-García;J. Pharm. Biomed. Anal.,2017

3. Equivalence of Generic glatiramer Acetate in Multiple Sclerosis: a randomized clinical trial;Cohen;JAMA Neurol.,2015

4. Annovazzi P., Bertolott A., Morra V.B. et al., A comprehensive review on Copemyl. Neurol Ther. DOI 10.1007/540120-017-0079.3

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