Chamberlain P - Search Results

1

Anti-drug Antibody Validation Testing and Reporting Harmonization.

Myler H, Pedras-Vasconcelos J, Phillips K, Hottenstein CS, Chamberlain P, Devanaryan V, Gleason C, Goodman J, Manning MS, Purushothama S, Richards S, Shen H, Zoghbi J, Amaravadi L, Barger T, Bowen S, Bowsher RR, Clements-Egan A, Geng D, Goletz TJ, Gunn GR, Hallett W, Hodsdon ME, Janelsins BM, Jawa V, Kamondi S, Kirshner S, Kramer D, Liang M, Lindley K, Liu S, Liu Z, McNally J, Mikulskis A, Nelson R, Ahbari MR, Qu Q, Ruppel J, Snoeck V, Song A, Yan H, Ware M. Myler H, et al. Among authors: chamberlain p. AAPS J. 2021 Dec 1;24(1):4. doi: 10.1208/s12248-021-00649-y. AAPS J. 2021. PMID: 34853961 Free PMC article.

2

European Immunogenicity Platform 11th Open Scientific Symposium on immunogenicity of biopharmaceuticals.

Tourdot S, Quaglia CB, Chamberlain P, De Groot AS, Dellas N, Guillemare E, Kromminga A, Lotz GP, Mingozzi F, Piccoli L, Pine S, Richards S, Waxenecker G, Kramer D. Tourdot S, et al. Among authors: chamberlain p. Bioanalysis. 2020 Aug;12(15):1043-1048. doi: 10.4155/bio-2020-0150. Epub 2020 Aug 17. Bioanalysis. 2020. PMID: 32803994

3

Immunogenicity Risk Assessment for an Engineered Human Cytokine Analogue Expressed in Different Cell Substrates.

Chamberlain P, Rup B. Chamberlain P, et al. AAPS J. 2020 Apr 14;22(3):65. doi: 10.1208/s12248-020-00443-2. AAPS J. 2020. PMID: 32291556 Review.

4

Effective presentation of immunogenicity risk assessments and related data in regulatory dossiers.

Chamberlain P. Chamberlain P. Bioanalysis. 2019 Sep;11(17):1581-1592. doi: 10.4155/bio-2018-0209. Epub 2019 Feb 15. Bioanalysis. 2019. PMID: 30767660

5

Pharmacodynamics, safety, and immunogenicity of Pelmeg^®, a pegfilgrastim biosimilar in healthy subjects.

Wessels H, Lehnick D, Höfler J, Jankowsky R, Chamberlain P, Roth K. Wessels H, et al. Among authors: chamberlain p. Pharmacol Res Perspect. 2019 Aug 13;7(5):e00507. doi: 10.1002/prp2.507. eCollection 2019 Oct. Pharmacol Res Perspect. 2019. PMID: 31417681 Free PMC article. Clinical Trial.

6

Assessing immunogenicity of biosimilar therapeutic monoclonal antibodies: regulatory and bioanalytical considerations.

Chamberlain P. Chamberlain P. Bioanalysis. 2013 Mar;5(5):561-74. doi: 10.4155/bio.13.6. Bioanalysis. 2013. PMID: 23425272 Review.

7

Taking immunogenicity assessment of therapeutic proteins to the next level.

Büttel IC, Chamberlain P, Chowers Y, Ehmann F, Greinacher A, Jefferis R, Kramer D, Kropshofer H, Lloyd P, Lubiniecki A, Krause R, Mire-Sluis A, Platts-Mills T, Ragheb JA, Reipert BM, Schellekens H, Seitz R, Stas P, Subramanyam M, Thorpe R, Trouvin JH, Weise M, Windisch J, Schneider CK. Büttel IC, et al. Among authors: chamberlain p. Biologicals. 2011 Mar;39(2):100-9. doi: 10.1016/j.biologicals.2011.01.006. Epub 2011 Feb 24. Biologicals. 2011. PMID: 21353596

8

Assessing the risk of undesirable immunogenicity/allergenicity of plant-derived therapeutic proteins.

Chamberlain PD. Chamberlain PD. Methods Mol Biol. 2009;483:325-39. doi: 10.1007/978-1-59745-407-0_19. Methods Mol Biol. 2009. PMID: 19183908

9

Controversies in Establishing Biosimilarity: Extrapolation of Indications and Global Labeling Practices.

Ebbers HC, Chamberlain P. Ebbers HC, et al. Among authors: chamberlain p. BioDrugs. 2016 Feb;30(1):1-8. doi: 10.1007/s40259-015-0154-1. BioDrugs. 2016. PMID: 26758077 Free PMC article.

10

An overview of scientific and regulatory issues for the immunogenicity of biological products.

Chamberlain P, Mire-Sluis AR. Chamberlain P, et al. Dev Biol (Basel). 2003;112:3-11. Dev Biol (Basel). 2003. PMID: 12762499 Review.

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