Works matching AU Vlieger, Jon

Results: 9

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.
Published in:
Rapid Communications in Mass Spectrometry: RCM, 2010, v. 24, n. 10, p. 1439, doi. 10.1002/rcm.4534
By:
- Giera, Martin;
- de Vlieger, Jon S. B.;
- Lingeman, Henk;
- Irth, Hubertus;
- Niessen, Wilfried M. A.
Publication type:
Article
Complex Drugs: What Are They and Why Do They Need Special Attention?
Published in:
Acta Pharmaceutica Hungarica, 2021, v. 91, n. 3/4, p. 110, doi. 10.33892/aph.2021.91.110-111
By:
- DE VLIEGER, JON S. B.
Publication type:
Article
A pragmatic regulatory approach for complex generics through the U.S. FDA 505(j) or 505(b)(2) approval pathways.
Published in:
Annals of the New York Academy of Sciences, 2021, v. 1502, n. 1, p. 5, doi. 10.1111/nyas.14662
By:
- Klein, Kevin;
- Borchard, Gerrit;
- Shah, Vinod P.;
- Flühmann, Beat;
- McNeil, Scott E.;
- de Vlieger, Jon S. B.
Publication type:
Article
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
By:
- 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.
Publication type:
Article
How to Regulate Nonbiological Complex Drugs (NBCD) and Their Follow-on Versions: Points to Consider.
Published in:
AAPS Journal, 2014, v. 16, n. 1, p. 15, doi. 10.1208/s12248-013-9533-z
By:
- Schellekens, Huub;
- Stegemann, Sven;
- Weinstein, Vera;
- de Vlieger, Jon S. B.;
- Flühmann, Beat;
- Mühlebach, Stefan;
- Gaspar, Rogério;
- Shah, Vinod P.;
- Crommelin, Daan J. A.
Publication type:
Article
Different Pharmaceutical Products Need Similar Terminology.
Published in:
AAPS Journal, 2014, v. 16, n. 1, p. 11, doi. 10.1208/s12248-013-9532-0
By:
- Crommelin, Daan J. A.;
- de Vlieger, Jon S. B.;
- Weinstein, Vera;
- Mühlebach, Stefan;
- Shah, Vinod P.;
- Schellekens, Huub
Publication type:
Article
On-line electrochemistry-bioaffinity screening with parallel HR-LC-MS for the generation and characterization of modified p38α kinase inhibitors.
Published in:
Analytical & Bioanalytical Chemistry, 2012, v. 403, n. 2, p. 367, doi. 10.1007/s00216-011-5663-2
By:
- Falck, David;
- Vlieger, Jon;
- Giera, Martin;
- Honing, Maarten;
- Irth, Hubertus;
- Niessen, Wilfried;
- Kool, Jeroen
Publication type:
Article
Development of an online p38α mitogen-activated protein kinase binding assay and integration of LC-HR-MS.
Published in:
Analytical & Bioanalytical Chemistry, 2010, v. 398, n. 4, p. 1771, doi. 10.1007/s00216-010-4087-8
By:
- Falck, David;
- De Vlieger, Jon S. B.;
- Niessen, Wilfried M. A.;
- Kool, Jeroen;
- Honing, Maarten;
- Giera, Martin;
- Irth, Hubertus
Publication type:
Article
Report of the AAPS Guidance Forum on the FDA Draft Guidance for Industry: "Drug Products, Including Biological Products, that Contain Nanomaterials".
Published in:
AAPS Journal, 2019, v. 21, n. 4, p. N.PAG, doi. 10.1208/s12248-019-0329-7
By:
- de Vlieger, Jon S. B.;
- Crommelin, Daan J. A.;
- Tyner, Katherine;
- Drummond, Daryl C.;
- Jiang, Wenlei;
- McNeil, Scott E.;
- Neervannan, Sesha;
- Crist, Rachael M.;
- Shah, Vinod P.
Publication type:
Article