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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. Shankar G, et al. Among authors: zuckerman la. J Pharm Biomed Anal. 2008 Dec 15;48(5):1267-81. doi: 10.1016/j.jpba.2008.09.020. Epub 2008 Sep 19. J Pharm Biomed Anal. 2008. PMID: 18993008 Review.
Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products.
Mire-Sluis AR, Barrett YC, Devanarayan V, Koren E, Liu H, Maia M, Parish T, Scott G, Shankar G, Shores E, Swanson SJ, Taniguchi G, Wierda D, Zuckerman LA. Mire-Sluis AR, et al. Among authors: zuckerman la. J Immunol Methods. 2004 Jun;289(1-2):1-16. doi: 10.1016/j.jim.2004.06.002. J Immunol Methods. 2004. PMID: 15251407
Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products.
Koren E, Smith HW, Shores E, Shankar G, Finco-Kent D, Rup B, Barrett YC, Devanarayan V, Gorovits B, Gupta S, Parish T, Quarmby V, Moxness M, Swanson SJ, Taniguchi G, Zuckerman LA, Stebbins CC, Mire-Sluis A. Koren E, et al. Among authors: zuckerman la. J Immunol Methods. 2008 Apr 20;333(1-2):1-9. doi: 10.1016/j.jim.2008.01.001. Epub 2008 Jan 29. J Immunol Methods. 2008. PMID: 18275969 Review.
Randomized trial of a dry-powder, fibrin sealant in vascular procedures.
Gupta N, Chetter I, Hayes P, O-Yurvati AH, Moneta GL, Shenoy S, Pribble JP, Zuckerman LA. Gupta N, et al. Among authors: zuckerman la. J Vasc Surg. 2015 Nov;62(5):1288-95. doi: 10.1016/j.jvs.2015.05.038. Epub 2015 Aug 5. J Vasc Surg. 2015. PMID: 26254451 Free article. Clinical Trial.
Fibrocaps for surgical hemostasis: two randomized, controlled phase II trials.
Verhoef C, Singla N, Moneta G, Muir W, Rijken A, Lockstadt H, de Wilt JHW, O-Yurvati A, Zuckerman LA, Frohna P, Porte RJ. Verhoef C, et al. Among authors: zuckerman la. J Surg Res. 2015 Apr;194(2):679-687. doi: 10.1016/j.jss.2014.12.011. Epub 2014 Dec 10. J Surg Res. 2015. PMID: 25586331 Clinical Trial.
The FINISH-3 trial: a phase 3, international, randomized, single-blind, controlled trial of topical fibrocaps in intraoperative surgical hemostasis.
Bochicchio GV, Gupta N, Porte RJ, Renkens KL, Pattyn P, Topal B, Troisi RI, Muir W, Chetter I, Gillen DL, Zuckerman LA, Frohna PA. Bochicchio GV, et al. Among authors: zuckerman la. J Am Coll Surg. 2015 Jan;220(1):70-81. doi: 10.1016/j.jamcollsurg.2014.09.019. Epub 2014 Oct 13. J Am Coll Surg. 2015. PMID: 25458801 Clinical Trial.
Preclinical safety of recombinant human thrombin.
Heffernan JK, Ponce RA, Zuckerman LA, Volpone JP, Visich J, Giste EE, Jenkins N, Boster D, Pederson S, Knitter G, Palmer T, Wills M, Early RJ, Rogge MC. Heffernan JK, et al. Among authors: zuckerman la. Regul Toxicol Pharmacol. 2007 Feb;47(1):48-58. doi: 10.1016/j.yrtph.2006.07.006. Epub 2006 Sep 12. Regul Toxicol Pharmacol. 2007. PMID: 16971028
18 results