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Review Khot, Sharma & Shah


16 Erickson HK, Lewis Phillips GD, Leipold DD et al. The effect of different linkers on target cell catabolism and pharmacokinetics/pharmacodynamics of trastuzumab maytansinoid conjugates. Mol. Cancer Ther. 11(5), 1133–1142 (2012).


17 Wada R, Erickson HK, Lewis Phillips GD et al. Mechanistic pharmacokinetic/pharmacodynamic modeling of in vivo tumor uptake, catabolism, and tumor response of trastuzumab maytansinoid conjugates. Cancer Chemother. Pharmacol. 74(5), 969–980 (2014).


18 Shah DK, Barletta F, Betts A, Hansel S. Key bioanalytical measurements for antibody–drug conjugate development: PK/PD modelers’ perspective. Bioanalysis 5(9), 989–992 (2013).


19 Shah DK, Balthasar JP. Predicting the effects of 8C2, a monoclonal anti-topotecan antibody, on plasma and tissue disposition of topotecan. J. Pharmacokinet. Pharmacodyn. 41(1), 55–69 (2014).


20 Shah DK, Balthasar JP. PK/TD modeling for prediction of the effects of 8C2, an anti-topotecan mAb, on topotecan- induced toxicity in mice. Int. J. Pharm. 465(1–2), 228–238 (2014).


21 Chen Y, Samineni D, Mukadam S et al. Physiologically based pharmacokinetic modeling as a tool to predict drug interactions for antibody–drug conjugates. Clin. Pharmacokinet. 54(1), 81–93 (2015).


22 Zhao B, Zheng S, Alley SC. Physiologically-based pharmacokinetic modeling of an anti-cd70 auristatin antibody–drug conjugate in tumor-bearing mice. Presented at: American Conference on Pharmacometrics 2011. San Diego, CA, 3–6 April 2011.


23 Shah DK, Betts AM. Towards a platform PBPK model to characterize the plasma and tissue disposition of monoclonal antibodies in preclinical species and human. J. Pharmacokinet. Pharmacodyn. 39(1), 67–86 (2012).


24 Garg A, Balthasar JP. Physiologically-based pharmacokinetic (PBPK) model to predict IgG tissue kinetics in wild-type and FcRn-knockout mice. J. Pharmacokinet. Pharmacodyn. 34(5), 687–709 (2007).


25 Jumbe NL, Xin Y, Leipold DD et al. Modeling the efficacy of trastuzumab-DM1, an antibody drug conjugate, in mice. J. Pharmacokinet. Pharmacodyn. 37(3), 221–242 (2010).


26 Haddish-Berhane N, Shah DK, Ma D et al. On translation of antibody drug conjugates efficacy from mouse experimental tumors to the clinic: a PK/PD approach. J. Pharmacokinet. Pharmacodyn. 40(5), 557–571 (2013).


27 Friberg LE, Henningsson A, Maas H, Nguyen L, Karlsson MO. Model of chemotherapy-induced myelosuppression with parameter consistency across drugs. J. Clin. Oncol. 20(24), 4713–4721 (2002).


28 Tatipalli M, Derendorf H. Semi-physiological population PK/PD model of ADC neutropenia. Pharm. Sci. [Masters]. University Of Florida, USA (2012).


29 Mugundu G, Vandendries E, Boni J. Use of pharmacokinetic- pharmacodynamic modeling to characterize platelet response following inotuzumab ozogamicin treatment in patients with follicular or diffuse large B-cell non-Hodgkin’s lymphoma Presented at: AACR 103rd Annual Meeting 2012. Chicago, USA, 31 March – 4 April 2012.


30 Bender BC, Schaedeli-Stark F, Koch R et al. A population pharmacokinetic/pharmacodynamic model of thrombocytopenia characterizing the effect of trastuzumab emtansine (T-DM1) on platelet counts in patients with HER2-positive metastatic breast cancer. Cancer Chemother. Pharmacol. 70(4), 591–601 (2012).


31 Firer MA. Antibody–drug conjugates in cancer therapy – filling in the potholes that lie ahead. OA Cancer 1(1), 8 (2013).


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Bioanalysis (2015) 7(13)


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