Equivalence of complex drug products: advances in and challenges for current regulatory frameworks.
- Published in:
- Annals of the New York Academy of Sciences, 2017, v. 1407, n. 1, p. 39, doi. 10.1111/nyas.13347
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- Article
Works matching AU Vlieger, Jon
Results: 9
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Structural elucidation of biologically active neomycin N-octyl derivatives in a regioisomeric mixture by means of liquid chromatography/ion trap time-of-flight mass spectrometry.
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- Rapid Communications in Mass Spectrometry: RCM, 2010, v. 24, n. 10, p. 1439, doi. 10.1002/rcm.4534
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- Article
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Report of the AAPS Guidance Forum on the FDA Draft Guidance for Industry: "Drug Products, Including Biological Products, that Contain Nanomaterials".
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- AAPS Journal, 2019, v. 21, n. 4, p. N.PAG, doi. 10.1208/s12248-019-0329-7
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- Article
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How to Regulate Nonbiological Complex Drugs (NBCD) and Their Follow-on Versions: Points to Consider.
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- AAPS Journal, 2014, v. 16, n. 1, p. 15, doi. 10.1208/s12248-013-9533-z
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- Article
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Different Pharmaceutical Products Need Similar Terminology.
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- AAPS Journal, 2014, v. 16, n. 1, p. 11, doi. 10.1208/s12248-013-9532-0
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- Publication type:
- Article
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Development of an online p38α mitogen-activated protein kinase binding assay and integration of LC-HR-MS.
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- Analytical & Bioanalytical Chemistry, 2010, v. 398, n. 4, p. 1771, doi. 10.1007/s00216-010-4087-8
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- Article
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A pragmatic regulatory approach for complex generics through the U.S. FDA 505(j) or 505(b)(2) approval pathways.
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- Annals of the New York Academy of Sciences, 2021, v. 1502, n. 1, p. 5, doi. 10.1111/nyas.14662
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- Article
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Complex Drugs: What Are They and Why Do They Need Special Attention?
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- Acta Pharmaceutica Hungarica, 2021, v. 91, n. 3/4, p. 110, doi. 10.33892/aph.2021.91.110-111
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- Article
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On-line electrochemistry-bioaffinity screening with parallel HR-LC-MS for the generation and characterization of modified p38α kinase inhibitors.
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- Analytical & Bioanalytical Chemistry, 2012, v. 403, n. 2, p. 367, doi. 10.1007/s00216-011-5663-2
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- Publication type:
- Article