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.
2. Overview of the nonclinical quality and toxicology testing for recombinant biopharmaceuticals produced in mammalian cells. Lebrec H, Narayanan P, Nims R. J Appl Toxicol; 2010 Jul; 30(5):387-96. PubMed ID: 20589744 [Abstract] [Full Text] [Related]
4. Alternative strategies for toxicity testing of species-specific biopharmaceuticals. Bussiere JL, Martin P, Horner M, Couch J, Flaherty M, Andrews L, Beyer J, Horvath C. Int J Toxicol; 2009 Jul; 28(3):230-53. PubMed ID: 19546261 [Abstract] [Full Text] [Related]
9. Considerations in assessing the developmental and reproductive toxicity potential of biopharmaceuticals. Martin PL, Breslin W, Rocca M, Wright D, Cavagnaro J. Birth Defects Res B Dev Reprod Toxicol; 2009 Jun; 86(3):176-203. PubMed ID: 19462404 [Abstract] [Full Text] [Related]
13. Metabolites in safety testing. Robison TW, Jacobs A. Bioanalysis; 2009 Oct; 1(7):1193-200. PubMed ID: 21083045 [Abstract] [Full Text] [Related]
14. Serum chemical biomarkers of cardiac injury for nonclinical safety testing. Walker DB. Toxicol Pathol; 2006 Oct; 34(1):94-104. PubMed ID: 16507550 [Abstract] [Full Text] [Related]
15. Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products. Shankar G, Devanarayan V, Amaravadi L, Barrett YC, Bowsher R, Finco-Kent D, Fiscella M, Gorovits B, Kirschner S, Moxness M, Parish T, Quarmby V, Smith H, Smith W, Zuckerman LA, Koren E. J Pharm Biomed Anal; 2008 Dec 15; 48(5):1267-81. PubMed ID: 18993008 [Abstract] [Full Text] [Related]
19. Study designs for the nonclinical safety testing of new vaccine products. Forster R. J Pharmacol Toxicol Methods; 2012 Jul 15; 66(1):1-7. PubMed ID: 22561062 [Abstract] [Full Text] [Related]