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Agonistic TAM-163 antibody targeting tyrosine kinase receptor-B: applying mechanistic modeling to enable preclinical to clinical translation and guide clinical trial design.

Vugmeyster Y, Rohde C, Perreault M, Gimeno RE, Singh P.

MAbs. 2013 May-Jun;5(3):373-83. doi: 10.4161/mabs.23826. Epub 2013 Mar 25.


The application of target information and preclinical pharmacokinetic/pharmacodynamic modeling in predicting clinical doses of a Dickkopf-1 antibody for osteoporosis.

Betts AM, Clark TH, Yang J, Treadway JL, Li M, Giovanelli MA, Abdiche Y, Stone DM, Paralkar VM.

J Pharmacol Exp Ther. 2010 Apr;333(1):2-13. doi: 10.1124/jpet.109.164129. Epub 2010 Jan 20.


Target-mediated drug disposition and prolonged liver accumulation of a novel humanized anti-CD81 monoclonal antibody in cynomolgus monkeys.

Vexler V, Yu L, Pamulapati C, Garrido R, Grimm HP, Sriraman P, Bohini S, Schraeml M, Singh U, Brandt M, Ries S, Ma H, Klumpp K, Ji C.

MAbs. 2013 Sep-Oct;5(5):776-86. doi: 10.4161/mabs.25642. Epub 2013 Jul 8.


Activation of TrkB with TAM-163 results in opposite effects on body weight in rodents and non-human primates.

Perreault M, Feng G, Will S, Gareski T, Kubasiak D, Marquette K, Vugmeyster Y, Unger TJ, Jones J, Qadri A, Hahm S, Sun Y, Rohde CM, Zwijnenberg R, Paulsen J, Gimeno RE.

PLoS One. 2013 May 20;8(5):e62616. doi: 10.1371/journal.pone.0062616. Print 2013.


Use of pharmacokinetic/ pharmacodynamic modelling for starting dose selection in first-in-human trials of high-risk biologics.

Agoram BM.

Br J Clin Pharmacol. 2009 Feb;67(2):153-60. doi: 10.1111/j.1365-2125.2008.03297.x. Epub 2008 Dec 11.


Population pharmacokinetic and pharmacodynamic modeling of MNRP1685A in cynomolgus monkeys using two-target quasi-steady-state (QSS) model.

Xin Y, Xiang H, Jin D, Theil FP, Joshi A, Damico-Beyer LA, Bai S.

J Pharmacokinet Pharmacodyn. 2012 Apr;39(2):217-26. doi: 10.1007/s10928-012-9244-6. Epub 2012 Mar 1.


Death receptor 5 agonistic antibody PRO95780: preclinical pharmacokinetics and concentration-effect relationship support clinical dose and regimen selection.

Xiang H, Reyes AE 2nd, Eppler S, Kelley S, Damico-Beyer LA.

Cancer Chemother Pharmacol. 2013 Aug;72(2):405-15. doi: 10.1007/s00280-013-2200-3. Epub 2013 Jun 16.


The minimum anticipated biological effect level (MABEL) for selection of first human dose in clinical trials with monoclonal antibodies.

Muller PY, Milton M, Lloyd P, Sims J, Brennan FR.

Curr Opin Biotechnol. 2009 Dec;20(6):722-9. doi: 10.1016/j.copbio.2009.10.013. Epub 2009 Nov 5. Review.


A model-based approach to predicting the human pharmacokinetics of a monoclonal antibody exhibiting target-mediated drug disposition.

Luu KT, Bergqvist S, Chen E, Hu-Lowe D, Kraynov E.

J Pharmacol Exp Ther. 2012 Jun;341(3):702-8. doi: 10.1124/jpet.112.191999. Epub 2012 Mar 13.


Quantitative prediction of human pharmacokinetics for monoclonal antibodies: retrospective analysis of monkey as a single species for first-in-human prediction.

Dong JQ, Salinger DH, Endres CJ, Gibbs JP, Hsu CP, Stouch BJ, Hurh E, Gibbs MA.

Clin Pharmacokinet. 2011 Feb;50(2):131-42. doi: 10.2165/11537430-000000000-00000.


Preclinical drug metabolism and pharmacokinetics, and prediction of human pharmacokinetics and efficacious dose of the investigational Aurora A kinase inhibitor alisertib (MLN8237).

Yang JJ, Li Y, Chakravarty A, Lu C, Xia CQ, Chen S, Pusalkar S, Zhang M, Ecsedy J, Manfredi MG, Wu JT, Shyu WC, Balani SK.

Drug Metab Lett. 2014 Jul;7(2):96-104.


Preclinical characterization of DEKAVIL (F8-IL10), a novel clinical-stage immunocytokine which inhibits the progression of collagen-induced arthritis.

Schwager K, Kaspar M, Bootz F, Marcolongo R, Paresce E, Neri D, Trachsel E.

Arthritis Res Ther. 2009;11(5):R142. doi: 10.1186/ar2814. Epub 2009 Sep 25.


Preclinical pharmacokinetics of MEHD7945A, a novel EGFR/HER3 dual-action antibody, and prediction of its human pharmacokinetics and efficacious clinical dose.

Kamath AV, Lu D, Gupta P, Jin D, Xiang H, Wong A, Leddy C, Crocker L, Schaefer G, Sliwkowski MX, Damico-Beyer LA.

Cancer Chemother Pharmacol. 2012 Apr;69(4):1063-9. doi: 10.1007/s00280-011-1806-6. Epub 2011 Dec 28.


Onartuzumab (MetMAb): using nonclinical pharmacokinetic and concentration-effect data to support clinical development.

Xiang H, Bender BC, Reyes AE 2nd, Merchant M, Jumbe NL, Romero M, Davancaze T, Nijem I, Mai E, Young J, Peterson A, Damico-Beyer LA.

Clin Cancer Res. 2013 Sep 15;19(18):5068-78. doi: 10.1158/1078-0432.CCR-13-0260. Epub 2013 Jul 26.


Preclinical pharmacokinetics of MFGR1877A, a human monoclonal antibody to FGFR3, and prediction of its efficacious clinical dose for the treatment of t(4;14)-positive multiple myeloma.

Kamath AV, Lu D, Gupta P, Jin D, Xin Y, Brady A, Stephan JP, Li H, Tien J, Qing J, Damico-Beyer LA.

Cancer Chemother Pharmacol. 2012 Apr;69(4):1071-8. doi: 10.1007/s00280-011-1807-5. Epub 2011 Dec 28.


Mechanistic pharmacokinetic/target engagement/pharmacodynamic (PK/TE/PD) modeling in deciphering interplay between a monoclonal antibody and its soluble target in cynomolgus monkeys.

Wang W, Wang X, Doddareddy R, Fink D, McIntosh T, Davis HM, Zhou H.

AAPS J. 2014 Jan;16(1):129-39. doi: 10.1208/s12248-013-9545-8. Epub 2013 Nov 28.


Target-mediated drug disposition model: relationships with indirect response models and application to population PK-PD analysis.

Gibiansky L, Gibiansky E.

J Pharmacokinet Pharmacodyn. 2009 Aug;36(4):341-51. doi: 10.1007/s10928-009-9125-9. Epub 2009 Jul 4.


Application of pharmacokinetics-pharmacodynamics/clinical response modeling and simulation for biologics drug development.

Zhao L, Shang EY, Sahajwalla CG.

J Pharm Sci. 2012 Dec;101(12):4367-82. doi: 10.1002/jps.23330. Epub 2012 Sep 27. Review.


Target-mediated pharmacokinetic and pharmacodynamic model of exendin-4 in rats, monkeys, and humans.

Gao W, Jusko WJ.

Drug Metab Dispos. 2012 May;40(5):990-7. doi: 10.1124/dmd.111.042291. Epub 2012 Feb 15.

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