Integration of bioanalytical measurements using PK–PD modeling and simulation: implications for antibody–drug conjugate development

A Priori Prediction of Tumor Payload Concentrations: Preclinical Case Study with an Auristatin-Based Anti-5T4 Antibody-Drug Conjugate

(2014) Dhaval K. Shah et al.   AAPS Journal

A Mechanistic Pharmacokinetic Model Elucidating the Disposition of Trastuzumab Emtansine (T-DM1), an Antibody–Drug Conjugate (ADC) for Treatment of Metastatic Breast Cancer

(2014) Brendan Bender et al.   AAPS Journal

Mechanistic pharmacokinetic/pharmacodynamic modeling of in vivo tumor uptake, catabolism, and tumor response of trastuzumab maytansinoid conjugates

(2014) Russ Wada et al.   CANCER CHEMOTHERAPY AND PHARMACOLOGY

Physiologically Based Pharmacokinetic Modeling as a Tool to Predict Drug Interactions for Antibody-Drug Conjugates

(2014) Yuan Chen et al.   CLINICAL PHARMACOKINETICS

PK/TD modeling for prediction of the effects of 8C2, an anti-topotecan mAb, on topotecan-induced toxicity in mice

(2014) Dhaval K. Shah et al.   INTERNATIONAL JOURNAL OF PHARMACEUTICS

Semi-mechanistic Multiple-Analyte Pharmacokinetic Model for an Antibody-Drug-Conjugate in Cynomolgus Monkeys

(2014) Dan Lu et al.   PHARMACEUTICAL RESEARCH

Mechanism-Based Pharmacokinetic/Pharmacodynamic Model for THIOMAB™ Drug Conjugates

(2014) Siddharth Sukumaran et al.   PHARMACEUTICAL RESEARCH

In Vitro and In Vivo Evaluation of Cysteine and Site Specific Conjugated Herceptin Antibody-Drug Conjugates

(2014) Dowdy Jackson et al.   PLoS One

An Integrated Multiple-Analyte Pharmacokinetic Model to Characterize Trastuzumab Emtansine (T-DM1) Clearance Pathways and to Evaluate Reduced Pharmacokinetic Sampling in Patients with HER2-Positive Metastatic Breast Cancer

(2013) Dan Lu et al.   CLINICAL PHARMACOKINETICS

Predicting the effects of 8C2, a monoclonal anti-topotecan antibody, on plasma and tissue disposition of topotecan

(2013) Dhaval K. Shah et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

Target-mediated drug disposition model and its approximations for antibody–drug conjugates

(2013) Leonid Gibiansky et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

On translation of antibody drug conjugates efficacy from mouse experimental tumors to the clinic: a PK/PD approach

(2013) Nahor Haddish-Berhane et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

Key bioanalytical measurements for antibody–drug conjugate development: PK/PD modelers’ perspective

(2013) Dhaval K Shah et al.   Bioanalysis

Bioanalysis of antibody–drug conjugates: American Association of Pharmaceutical Scientists Antibody–Drug Conjugate Working Group position paper

(2013) Boris Gorovits et al.   Bioanalysis

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

(2012) Brendan C. Bender et al.   CANCER CHEMOTHERAPY AND PHARMACOLOGY

Semi-mechanistic Population Pharmacokinetic Model of Multivalent Trastuzumab Emtansine in Patients with Metastatic Breast Cancer

(2012) V L Chudasama et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Bench to bedside translation of antibody drug conjugates using a multiscale mechanistic PK/PD model: a case study with brentuximab-vedotin

(2012) Dhaval K. Shah et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

The Effect of Different Linkers on Target Cell Catabolism and Pharmacokinetics/Pharmacodynamics of Trastuzumab Maytansinoid Conjugates

(2012) H. K. Erickson et al.   MOLECULAR CANCER THERAPEUTICS

Conjugation site modulates the in vivo stability and therapeutic activity of antibody-drug conjugates

(2012) Ben-Quan Shen et al.   NATURE BIOTECHNOLOGY

Towards a platform PBPK model to characterize the plasma and tissue disposition of monoclonal antibodies in preclinical species and human

(2011) Dhaval K. Shah et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

Intracellular Activation of SGN-35, a Potent Anti-CD30 Antibody-Drug Conjugate

(2010) N. M. Okeley et al.   CLINICAL CANCER RESEARCH

Modeling the efficacy of trastuzumab-DM1, an antibody drug conjugate, in mice

(2010) Nelson L. Jumbe et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

The Pharmacologic Basis for Antibody-Auristatin Conjugate Activity

(2009) S. C. Alley et al.   JOURNAL OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS