190 related articles for article (PubMed ID: 23146362)
21. Major degradation product identified in several pharmaceutical formulations against the common cold.
Marín A; Espada A; Vidal P; Barbas C
Anal Chem; 2005 Jan; 77(2):471-7. PubMed ID: 15649042
[TBL] [Abstract][Full Text] [Related]
22. The role of formulation in insulin comparability assessments.
Defelippis MR; Larimore FS
Biologicals; 2006 Mar; 34(1):49-54. PubMed ID: 16330222
[TBL] [Abstract][Full Text] [Related]
23. Predicting solution aggregation rates for therapeutic proteins: approaches and challenges.
Roberts CJ; Das TK; Sahin E
Int J Pharm; 2011 Oct; 418(2):318-33. PubMed ID: 21497188
[TBL] [Abstract][Full Text] [Related]
24. Characterizing biological products and assessing comparability following manufacturing changes.
Chirino AJ; Mire-Sluis A
Nat Biotechnol; 2004 Nov; 22(11):1383-91. PubMed ID: 15529163
[TBL] [Abstract][Full Text] [Related]
25. Structural mass spectrometry in biologics discovery: advances and future trends.
Mo J; Tymiak AA; Chen G
Drug Discov Today; 2012 Dec; 17(23-24):1323-30. PubMed ID: 22819924
[TBL] [Abstract][Full Text] [Related]
26. An industry perspective on the monitoring of subvisible particles as a quality attribute for protein therapeutics.
Singh SK; Afonina N; Awwad M; Bechtold-Peters K; Blue JT; Chou D; Cromwell M; Krause HJ; Mahler HC; Meyer BK; Narhi L; Nesta DP; Spitznagel T
J Pharm Sci; 2010 Aug; 99(8):3302-21. PubMed ID: 20310025
[TBL] [Abstract][Full Text] [Related]
27. Regulatory guideline for biosimilar products in Korea.
Suh SK; Park Y
Biologicals; 2011 Sep; 39(5):336-8. PubMed ID: 21784653
[TBL] [Abstract][Full Text] [Related]
28. Applications of mass spectrometry for the structural characterization of recombinant protein pharmaceuticals.
Srebalus Barnes CA; Lim A
Mass Spectrom Rev; 2007; 26(3):370-88. PubMed ID: 17410555
[TBL] [Abstract][Full Text] [Related]
29. Comparability is not just analytical equivalence.
Lubiniecki AS; Marcia Federici M
Biologicals; 2006 Mar; 34(1):45-7. PubMed ID: 16330221
[No Abstract] [Full Text] [Related]
30. Comparative testing and pharmacovigilance of biosimilars.
Locatelli F; Roger S
Nephrol Dial Transplant; 2006 Oct; 21 Suppl 5():v13-6. PubMed ID: 16959789
[TBL] [Abstract][Full Text] [Related]
31. Protein-excipient interactions: mechanisms and biophysical characterization applied to protein formulation development.
Kamerzell TJ; Esfandiary R; Joshi SB; Middaugh CR; Volkin DB
Adv Drug Deliv Rev; 2011 Oct; 63(13):1118-59. PubMed ID: 21855584
[TBL] [Abstract][Full Text] [Related]
32. Online electrochemistry/mass spectrometry in drug metabolism studies: principles and applications.
Baumann A; Karst U
Expert Opin Drug Metab Toxicol; 2010 Jun; 6(6):715-31. PubMed ID: 20370599
[TBL] [Abstract][Full Text] [Related]
33. Integrated strategies for assessment of metabolite exposure in humans during drug development: analytical challenges and clinical development considerations.
Zhu M; Zhang D; Zhang H; Shyu WC
Biopharm Drug Dispos; 2009 May; 30(4):163-84. PubMed ID: 19544287
[TBL] [Abstract][Full Text] [Related]
34. Analytical techniques for the evaluation of liquid protein therapeutics.
Tatford OC; Gomme PT; Bertolini J
Biotechnol Appl Biochem; 2004 Aug; 40(Pt 1):67-81. PubMed ID: 15270709
[TBL] [Abstract][Full Text] [Related]
35. Analytical methods for drugs in the next decade.
Zarembo JE
J Assoc Off Anal Chem; 1982 May; 65(3):542-50. PubMed ID: 7096237
[TBL] [Abstract][Full Text] [Related]
36. High-resolution MS for structural characterization of protein therapeutics: advances and future directions.
Wei H; Tymiak AA; Chen G
Bioanalysis; 2013 May; 5(10):1299-313. PubMed ID: 23721450
[TBL] [Abstract][Full Text] [Related]
37. The application of MALDI TOF MS in biopharmaceutical research.
Kafka AP; Kleffmann T; Rades T; McDowell A
Int J Pharm; 2011 Sep; 417(1-2):70-82. PubMed ID: 21147205
[TBL] [Abstract][Full Text] [Related]
38. On the Analytical Superiority of 1D NMR for Fingerprinting the Higher Order Structure of Protein Therapeutics Compared to Multidimensional NMR Methods.
Poppe L; Jordan JB; Rogers G; Schnier PD
Anal Chem; 2015 Jun; 87(11):5539-45. PubMed ID: 25929316
[TBL] [Abstract][Full Text] [Related]
39. Overall impact of the regulatory requirements for genotoxic impurities on the drug development process.
Giordani A; Kobel W; Gally HU
Eur J Pharm Sci; 2011 May; 43(1-2):1-15. PubMed ID: 21420491
[TBL] [Abstract][Full Text] [Related]
40. Summary of the diverse situation of similar biotherapeutic products in the selected countries (August 2010).
Kang HN
Biologicals; 2011 Sep; 39(5):304-7. PubMed ID: 21880507
[TBL] [Abstract][Full Text] [Related]
[Previous] [Next] [New Search]
