Equivalence of complex drug products: advances in and challenges for current regulatory frameworks von Hussaarts, Leonie, Mühlebach, Stefan, Shah, Vinod P., McNeil, Scott, Borchard, Gerrit, Flühmann, Beat, Weinstein, Vera, Neervannan, Sesha, Griffiths, Elwyn, Jiang, Wenlei, Wolff‐Holz, Elena, Crommelin, Daan J.A., Vlieger, Jon S.B.

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Physicochemical and Biological Examination of Two Glatiramer Acetate Products von Komlosh, Arthur, Weinstein, Vera, Loupe, Pippa, Hasson, Tal, Timan, Bracha, Konya, Attila, Alexander, Jessica, Melamed-Gal, Sigal, Nock, Steffen

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The similarity question for biologicals and non-biological complex drugs von Crommelin, Daan J.A., Shah, Vinod P., Klebovich, Imre, McNeil, Scott E., Weinstein, Vera, Flühmann, Beat, Mühlebach, Stefan, de Vlieger, Jon S.B.

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How to Regulate Nonbiological Complex Drugs (NBCD) and Their Follow-on Versions: Points to Consider von Schellekens, Huub, Stegemann, Sven, Weinstein, Vera, de Vlieger, Jon S. B., Flühmann, Beat, Mühlebach, Stefan, Gaspar, Rogério, Shah, Vinod P., Crommelin, Daan J. A.

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Defining Glatiramer Acetate: The USA Definition of Sameness and the EU Definition of Similarity (P3.415) von Melamed-Gal, Sigal, Loupe, Pippa, Grossman, Iris, Zeskind, Benjamin, Weinstein, Vera, Timan, Bracha, Kolitz, Sarah, Komlosh, Arthur, Hasson, Tal, Sahly, Yousif

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Different Pharmaceutical Products Need Similar Terminology von Crommelin, Daan J. A., de Vlieger, Jon S. B., Weinstein, Vera, Mühlebach, Stefan, Shah, Vinod P., Schellekens, Huub

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Compositional differences between Copaxone and Glatopa are reflected in altered immunomodulation ex vivo in a mouse model von Grossman, Iris, Kolitz, Sarah, Komlosh, Arthur, Zeskind, Benjamin, Weinstein, Vera, Laifenfeld, Daphna, Gilbert, Adrian, Bar‐Ilan, Oren, Fowler, Kevin D., Hasson, Tal, Konya, Attila, Wells‐Knecht, Kevin, Loupe, Pippa, Melamed‐Gal, Sigal, Molotsky, Tatiana, Krispin, Revital, Papir, Galia, Sahly, Yousif, Hayden, Michael R.

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The glatiramoid class of immunomodulator drugs von Varkony, Haim, Weinstein, Vera, Klinger, Ety, Sterling, Jeffrey, Cooperman, Helena, Komlosh, Turi, Ladkani, David, Schwartz, Rivka

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Integrated Transcriptomic and Physicochemical Characterization of Glatiramer Acetate Products (Copaxone and Glatopa) Available in the United States (P1.370) von Komlosh, Arthur, Laifenfeld, Daphna, Kolitz, Sarah, Fowler, Kevin, Hasson, Tal, Konya, Attila, Bakshi, Shlomo, Zeskind, Benjamin, Zhang, Jenny, Wells-Knecht, Kevin, Molotsky, Tatiana, Krispin, Revital, Papir, Galia, Pinkert, Dalia, Cooperman, Helena, Weinstein, Vera, Sahly, Yousif, Loupe, Pippa, Melamed-Gal, Sigal, Grossman, Iris, Hayden, Michael

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Physicochemical and Biological Characterization of both Copaxone and the European Follow-On Glatiramer Acetate Product (P1.400) von Timan, Bracha, Komlosh, Arthur, Beriozkin, Olga, Konya, Attila, Wells-Knecht, Kevin, Weinstein, Vera, Sahly, Yousif, Gilbert, Adrian, Bar-Ilan, Oren, Zhang, Jenny, Funt, Jason, Hasson, Tal, Laifenfeld, Daphne, Kolitz, Sarah, Zeskind, Benjamin, Melamed-Gal, Sigal, Loupe, Pippa, Grossman, Iris, Laufer, Ralph, Hayden, Michael

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Response to the Letter-to-the Editor by Cohen et al. concerning our eNeurologicalSci article, Melamed-Gal, et al. Physicochemical, biological, functional and toxicological characte... von Melamed-Gal, Sigal, Loupe, Pippa, Timan, Bracha, Weinstein, Vera, Kolitz, Sarah, Zhang, Jenny, Funt, Jason, Komlosh, Arthur, Ashkenazi, Nurit, Bar-Ilan, Oren, Konya, Attila, Beriozkin, Olga, Laifenfeld, Daphna, Hasson, Tal, Zeskind, Benjamin, Hayden, Michael, Nock, Steffen, Grossman, Iris

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The authorization of non-biological complex drugs (NBCDs) follow-on versions: specific regulatory and interchangeability rules ahead? von Muhlebach, Stefan, Vulto, Arnold, SB de Vlieger, Jon S.B, Weinstein, Vera, Fluhmann, Beat, Shah, Vinod P

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Non-biological complex drugs (NBCDs) and their follow-on versions: time for an editorial section von de Vlieger, Jon S.B, Muhlebach, Stefan, Shah, Vinod P, McNeil, Scott E, Borchard, Gerrit, Weinstein, Vera, Fluhmann, Beat, Neervannan, Sesha, Crommelin, Daan J.A

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The authorization of non-biological complex drugs von Weinstein, Vera, Shah, Vinod P, Vulto, Arnold, SB de Vlieger, Jon S.B, Fluhmann, Beat, Muhlebach, Stefan

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Glatiramoids von Weinstein, Vera, Schwartz, Rivka, Grossman, Iris, Zeskind, Benjamin, Nicholas, J. Michael

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Isolation of optically pure (−)-linalyl acetate from clary sage, Salvia dominica L., Lavender and Lavandin von Ravid, Uzi, Putievsky, Eli, Bassat, Michal, Ikan, Raphael, Weinstein, Vera

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PARENTERAL FORMULATIONS OF PEPTIDES FOR THE TREATMENT OF SYSTEMIC LUPUS ERYTHEMATOSUS von COHEN-VERED, SHARON, NAFTALI, ESMIRA, KLINGER, ETY, GILBERT, ADRIAN, WEINSTEIN, VERA

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Testing the Limits of Ion Mobility Mass Spectrometry to Compare a Nonbiological Complex Drug Product and Purported Generics-A Case Study with Copaxone von Wells-Knecht, Kevin J, Denny, Richard, Hasson, Tal, Komlosh, Arthur, Neeson, Kieran, Riches, Eleanor, Weinstein, Vera

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Determination of the enantiomeric composition of citronellol in essential oils by chiral GC analysis on a modified γ-cyclodextrin phase von Ravid, Uzi, Putievsky, Eli, Katzir, Irena, Ikan, Raphael, Weinstein, Vera

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Parenterale formuleringer af peptide til behandling af systemisk lupus erythematosus von GILBERT, Adrian, KLINGER, Ety, WEINSTEIN, Vera, COHEN-VERED, Sharon, NAFTALI, Esmira

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