These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.
6. Practical approaches to dose selection for first-in-human clinical trials with novel biopharmaceuticals. Tibbitts J; Cavagnaro JA; Haller CA; Marafino B; Andrews PA; Sullivan JT Regul Toxicol Pharmacol; 2010 Nov; 58(2):243-51. PubMed ID: 20558225 [TBL] [Abstract][Full Text] [Related]
7. Aggregates in monoclonal antibody manufacturing processes. Vázquez-Rey M; Lang DA Biotechnol Bioeng; 2011 Jul; 108(7):1494-508. PubMed ID: 21480193 [TBL] [Abstract][Full Text] [Related]
8. Translational strategies for development of monoclonal antibodies from discovery to the clinic. Tabrizi MA; Bornstein GG; Klakamp SL; Drake A; Knight R; Roskos L Drug Discov Today; 2009 Mar; 14(5-6):298-305. PubMed ID: 19152840 [TBL] [Abstract][Full Text] [Related]
9. Human antibodies from transgenic animals. Lonberg N Nat Biotechnol; 2005 Sep; 23(9):1117-25. PubMed ID: 16151405 [TBL] [Abstract][Full Text] [Related]
10. [Brief overview on the studies of monoclonal antibody]. Tsukagoshi S Nihon Rinsho; 2002 Mar; 60(3):435-8. PubMed ID: 11904954 [TBL] [Abstract][Full Text] [Related]
11. FDA perspective on specifications for biotechnology products--from IND to PLA. Murano G Dev Biol Stand; 1997; 91():3-13. PubMed ID: 9413677 [TBL] [Abstract][Full Text] [Related]
12. Hazard identification and risk assessment for biologics targeting the immune system. Weir AB J Immunotoxicol; 2008 Jan; 5(1):3-10. PubMed ID: 18382852 [TBL] [Abstract][Full Text] [Related]
13. Pharmacokinetic, pharmacodynamic and immunogenicity comparability assessment strategies for monoclonal antibodies. Putnam WS; Prabhu S; Zheng Y; Subramanyam M; Wang YM Trends Biotechnol; 2010 Oct; 28(10):509-16. PubMed ID: 20691488 [TBL] [Abstract][Full Text] [Related]
19. Using partition designs to enhance purification process understanding. Pieracci J; Perry L; Conley L Biotechnol Bioeng; 2010 Dec; 107(5):814-24. PubMed ID: 20632374 [TBL] [Abstract][Full Text] [Related]
20. Criteria for investigation of the product equivalence of monoclonal antibodies for therapeutic and in vivo-diagnostic use in case of introduction of changes in the manufacturing process. Schäffner G; Haase M; Giess S Biologicals; 1995 Sep; 23(3):253-9. PubMed ID: 8527127 [TBL] [Abstract][Full Text] [Related] [Next] [New Search]