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Pharmacokinetics and safety of subcutaneous rituximab in follicular lymphoma (SABRINA): stage 1 analysis of a randomised phase 3 study

The lancet oncology, 2014-03, Vol.15 (3), p.343-352

2014

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Combining mathematical modeling, in vitro data and clinical target expression to support bispecific antibody binding affinity selection: a case example with FAP-4-1BBL

Frontiers in pharmacology, 2024-10, Vol.15, p.1472662

2024

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Subcutaneous Rituximab for the Treatment of B-Cell Hematologic Malignancies: A Review of the Scientific Rationale and Clinical Development

Advances in therapy, 2017-10, Vol.34 (10), p.2210-2231

2017

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A model‐based approach leveraging in vitro data to support dose selection from the outset: A framework for bispecific antibodies in immuno‐oncology

CPT: pharmacometrics and systems pharmacology, 2023-11, Vol.12 (11), p.1804-1818

2023

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Pharmacokinetics, safety, and efficacy of subcutaneous versus intravenous rituximab plus chemotherapy as treatment for chronic lymphocytic leukaemia (SAWYER): a phase 1b, open-label, randomised controlled non-inferiority trial

The Lancet. Haematology, 2016-03, Vol.3 (3), p.e128-e138

2016

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Comparison of Subcutaneous and Intravenous Administration of Trastuzumab: A Phase I/Ib Trial in Healthy Male Volunteers and Patients With HER2-Positive Breast Cancer

Journal of clinical pharmacology, 2013-02, Vol.53 (2), p.192-201

2013

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Quantitative Clinical Pharmacology Supports the Bridging From i.v. Dosing and Approval of s.c. Rituximab in B‐Cell Hematological Malignancies

Clinical pharmacology and therapeutics, 2021-11, Vol.110 (5), p.1261-1272

2021

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A first-in-human study of the fibroblast activation protein-targeted, 4-1BB agonist RO7122290 in patients with advanced solid tumors

Science translational medicine, 2023-05, Vol.15 (695), p.eabp9229

2023

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Comparison of Subcutaneous Versus Intravenous Administration of Rituximab As Maintenance Treatment for Follicular Lymphoma: Results From a Two-Stage, Phase IB Study

Journal of clinical oncology, 2014-06, Vol.32 (17), p.1782-1791

2014

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Pharmacokinetics and safety of subcutaneous rituximab plus fludarabine and cyclophosphamide for patients with chronic lymphocytic leukaemia

British journal of clinical pharmacology, 2015-11, Vol.80 (5), p.1001-1009

2015

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Effect of Vemurafenib on the Pharmacokinetics of a Single Dose of Digoxin in Patients With BRAF V600 Mutation-Positive Metastatic Malignancy

Journal of clinical pharmacology, 2018-08, Vol.58 (8), p.1067-1073

2018

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Mechanistic Investigations of Diarrhea Toxicity Induced by Anti-HER2/3 Combination Therapy

Molecular cancer therapeutics, 2018-07, Vol.17 (7), p.1464-1474

2018

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A continuous-time multistate Markov model to describe the occurrence and severity of diarrhea events in metastatic breast cancer patients treated with lumretuzumab in combination with pertuzumab and paclitaxel

Cancer chemotherapy and pharmacology, 2018-09, Vol.82 (3), p.395-406

2018

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Efficacy and Safety of Subcutaneous or Intravenous Administration of Rituximab in Patients with CD20+ Diffuse Large B-Cell Lymphoma or Follicular Lymphoma: Final Results of the Randomized, Open-Label, Crossover, PrefMab Study

Blood, 2017-12, Vol.130, p.2834-2834

2017

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Accelerating drug development by efficiently using emerging PK/PD data from an adaptable entry-into-human trial: example of lumretuzumab

Cancer chemotherapy and pharmacology, 2017-06, Vol.79 (6), p.1239-1247

2017

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Effect of Vemurafenib on the Pharmacokinetics of a Single Dose of Digoxin in Patients With BRAFV600 Mutation–Positive Metastatic Malignancy

Journal of clinical pharmacology, 2018-08, Vol.58 (8), p.1067-1073

2018

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A pediatric brain tumor consortium phase II trial of capecitabine rapidly disintegrating tablets with concomitant radiation therapy in children with newly diagnosed diffuse intrinsic pontine gliomas

Pediatric blood & cancer, 2018-02, Vol.65 (2), p.n/a

2018

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Effect of Vemurafenib on the Pharmacokinetics of a Single Dose of Tizanidine (a CYP1A2 Substrate) in Patients With BRAF V600 Mutation-Positive Malignancies

Clinical pharmacology in drug development, 2020-07, Vol.9 (5), p.651-658

2020

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Pharmacokinetics and pharmacodynamics of single subcutaneous doses of tocilizumab administered with or without rHuPH20

International journal of clinical pharmacology and therapeutics, 2013-07, Vol.51 (7), p.537-548

2013

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Effect of Vemurafenib on the Pharmacokinetics of a Single Dose of Tizanidine (a CYP1A2 Substrate) in Patients With BRAFV600 Mutation–Positive Malignancies

Clinical pharmacology in drug development, 2020-07, Vol.9 (5), p.651-658

2020

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Reply to: Letter to the editor "Subcutaneous herceptin therapy"

Journal of clinical pharmacology, 2013-12, Vol.53 (12), p.1343-1344

2013

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Non-Inferior Pharmacokinetics with Comparable Safety and Response Rates for Subcutaneous (SC), Compared with Intravenous (IV), Rituximab in Combination with Fludarabine and Cyclophosphamide (FC) in Patients (Pts) with Untreated Chronic Lymphocytic Leukemia (CLL): Part 2 of the Phase Ib SAWYER Study (BO25341)

Blood, 2014-12, Vol.124 (21), p.1995-1995

2014

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A Two-Stage Phase Ib Study to Investigate the Pharmacokinetics, Safety and Tolerability of Subcutaneous Rituximab In Patients with Follicular Lymphoma as Part of Maintenance Treatment

Blood, 2010-11, Vol.116 (21), p.2858-2858

2010

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Reply to: Letter to the editor “Subcutaneous herceptin therapy”: The Journal of Clinical Pharmacology

Journal of clinical pharmacology, 2013-12, Vol.53 (12), p.1343-1344

2013

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Effect of Rifampicin on the Pharmacokinetics of a Single Dose of Vemurafenib in Patients With BRAFV600 Mutation–Positive Metastatic Malignancy

Clinical pharmacology in drug development, 2019-08, Vol.8 (6), p.837-843

2019

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Pharmacokinetics and safety of subcutaneous rituximab in follicular lymphoma (SABRINA): stage 1 analysis of a randomised phase 3 study

Combining mathematical modeling, in vitro data and clinical target expression to support bispecific antibody binding affinity selection: a case example with FAP-4-1BBL

Subcutaneous Rituximab for the Treatment of B-Cell Hematologic Malignancies: A Review of the Scientific Rationale and Clinical Development

A model‐based approach leveraging in vitro data to support dose selection from the outset: A framework for bispecific antibodies in immuno‐oncology

Pharmacokinetics, safety, and efficacy of subcutaneous versus intravenous rituximab plus chemotherapy as treatment for chronic lymphocytic leukaemia (SAWYER): a phase 1b, open-label, randomised controlled non-inferiority trial

Comparison of Subcutaneous and Intravenous Administration of Trastuzumab: A Phase I/Ib Trial in Healthy Male Volunteers and Patients With HER2-Positive Breast Cancer

Quantitative Clinical Pharmacology Supports the Bridging From i.v. Dosing and Approval of s.c. Rituximab in B‐Cell Hematological Malignancies

A first-in-human study of the fibroblast activation protein-targeted, 4-1BB agonist RO7122290 in patients with advanced solid tumors

Comparison of Subcutaneous Versus Intravenous Administration of Rituximab As Maintenance Treatment for Follicular Lymphoma: Results From a Two-Stage, Phase IB Study

Pharmacokinetics and safety of subcutaneous rituximab plus fludarabine and cyclophosphamide for patients with chronic lymphocytic leukaemia

Effect of Vemurafenib on the Pharmacokinetics of a Single Dose of Digoxin in Patients With BRAF V600 Mutation-Positive Metastatic Malignancy

Mechanistic Investigations of Diarrhea Toxicity Induced by Anti-HER2/3 Combination Therapy

A continuous-time multistate Markov model to describe the occurrence and severity of diarrhea events in metastatic breast cancer patients treated with lumretuzumab in combination with pertuzumab and paclitaxel

Efficacy and Safety of Subcutaneous or Intravenous Administration of Rituximab in Patients with CD20+ Diffuse Large B-Cell Lymphoma or Follicular Lymphoma: Final Results of the Randomized, Open-Label, Crossover, PrefMab Study

Accelerating drug development by efficiently using emerging PK/PD data from an adaptable entry-into-human trial: example of lumretuzumab

Effect of Vemurafenib on the Pharmacokinetics of a Single Dose of Digoxin in Patients With BRAFV600 Mutation–Positive Metastatic Malignancy

A pediatric brain tumor consortium phase II trial of capecitabine rapidly disintegrating tablets with concomitant radiation therapy in children with newly diagnosed diffuse intrinsic pontine gliomas

Effect of Vemurafenib on the Pharmacokinetics of a Single Dose of Tizanidine (a CYP1A2 Substrate) in Patients With BRAF V600 Mutation-Positive Malignancies

Pharmacokinetics and pharmacodynamics of single subcutaneous doses of tocilizumab administered with or without rHuPH20

Effect of Vemurafenib on the Pharmacokinetics of a Single Dose of Tizanidine (a CYP1A2 Substrate) in Patients With BRAFV600 Mutation–Positive Malignancies

Reply to: Letter to the editor "Subcutaneous herceptin therapy"

A Two-Stage Phase Ib Study to Investigate the Pharmacokinetics, Safety and Tolerability of Subcutaneous Rituximab In Patients with Follicular Lymphoma as Part of Maintenance Treatment

Reply to: Letter to the editor “Subcutaneous herceptin therapy”: The Journal of Clinical Pharmacology

Effect of Rifampicin on the Pharmacokinetics of a Single Dose of Vemurafenib in Patients With BRAFV600 Mutation–Positive Metastatic Malignancy

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