Application of Pharmacokinetic-Pharmacodynamic Modeling and Simulation 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

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

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

Model-Based Drug Development: A Rational Approach to Efficiently Accelerate Drug Development

(2013) P A Milligan et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

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

Antibody biodistribution coefficients

(2013) Dhaval K. Shah et al.   mAbs

Site-specific antibody drug conjugates for cancer therapy

(2013) Siler Panowski et al.   mAbs

Antibody-drug conjugate model fast characterization by LC-MS following IdeS proteolytic digestion

(2013) Elsa Wagner-Rousset et al.   mAbs

The antibody-drug conjugate: an enabling modality for natural product-based cancer therapeutics

(2013) Hans-Peter Gerber et al.   NATURAL PRODUCT REPORTS

Maturing antibody–drug conjugate pipeline hits 30

(2013) Asher Mullard   NATURE REVIEWS DRUG DISCOVERY

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

Brentuximab Vedotin: A New Age in the Treatment of Hodgkin Lymphoma and Anaplastic Large Cell Lymphoma

(2012) Stephanie S Minich   ANNALS OF PHARMACOTHERAPY

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 determination and interpretation of the therapeutic index in drug development

(2012) Patrick Y. Muller et al.   NATURE REVIEWS DRUG DISCOVERY

Clinical Implications of Pathophysiological and Demographic Covariates on the Population Pharmacokinetics of Trastuzumab Emtansine, a HER2-Targeted Antibody-Drug Conjugate, in Patients With HER2-Positive Metastatic Breast Cancer

(2011) Manish Gupta et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Mathematical modeling to distinguish cell cycle arrest and cell killing in chemotherapeutic concentration response curves

(2011) Salaheldin S. Hamed et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

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

A Systems Approach for Tumor Pharmacokinetics

(2011) Greg Michael Thurber et al.   PLoS One

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

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

Physiologically based pharmacokinetic model for topotecan in mice

(2010) Dhaval K. Shah et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

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

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

A modeling analysis of the effects of molecular size and binding affinity on tumor targeting

(2009) M. M. Schmidt et al.   MOLECULAR CANCER THERAPEUTICS