Biologics During Pregnancy and Breastfeeding Among Women With Rheumatic Diseases: Safety Clinical Evidence on the Road

Ixekizumab treatment of biologic-naïve patients with active psoriatic arthritis: 3-year results from a phase III clinical trial (SPIRIT-P1)

(2020) Vinod Chandran et al.   RHEUMATOLOGY

2020 American College of Rheumatology Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases

(2020) Lisa R. Sammaritano et al.   Arthritis & Rheumatology

Belimumab Concentrations in Maternal Serum and Breast Milk During Breastfeeding and the Safety Assessment of the Infant: A Case Study

(2020) Jumpei Saito et al.   Breastfeeding Medicine

Assessment of placental disposition of infliximab and etanercept in women with autoimmune disease and in the ex vivo perfused placenta

(2020) Gaby A.M. Eliesen et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Safety and optimal timing of BCG vaccination in infants born to mothers receiving anti-TNF therapy for inflammatory bowel disease

(2020) Sang Hyoung Park et al.   Journal of Crohns & Colitis

Safety of ixekizumab in adult patients with plaque psoriasis, psoriatic arthritis and axial spondyloarthritis: data from 21 clinical trials

(2020) Mark C Genovese et al.   RHEUMATOLOGY

Rheumatoid arthritis–associated interstitial lung disease: an overview of epidemiology, pathogenesis and management

(2020) Yujie Dai et al.   CLINICAL RHEUMATOLOGY

Safety of New Biologics (Vedolizumab and Ustekinumab) and Small Molecules (Tofacitinib) During Pregnancy: A Review

(2020) Javier P. Gisbert et al.   DRUGS

Rituximab use as induction therapy for lupus nephritis: a systematic review

(2020) Liya Stolyar et al.   LUPUS

Placental disposition of eculizumab, C5 and C5‐eculizumab in two pregnancies of a woman with paroxysmal nocturnal haemoglobinuria

(2020) Gaby A.M. Eliesen et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Belimumab as Add-on Therapy in Lupus Nephritis

(2020) Michael Ward et al.   NEW ENGLAND JOURNAL OF MEDICINE

Abatacept in interstitial lung disease associated with rheumatoid arthritis: national multicenter study of 263 patients

(2020) Carlos Fernández-Díaz et al.   RHEUMATOLOGY

Pyoderma gangrenosum

(2020) Emanual Maverakis et al.   Nature Reviews Disease Primers

Immunosuppressives and biologics during pregnancy and lactation

(2019) Antonia Puchner et al.   WIENER KLINISCHE WOCHENSCHRIFT

Treatment of refractory poor aPL-related obstetric outcomes with TNF-alpha blockers: Maternal-fetal outcomes in a series of 18 cases

(2019) Jaume Alijotas-Reig et al.   SEMINARS IN ARTHRITIS AND RHEUMATISM

Advances in antibody engineering for rheumatic diseases

(2019) Anja S. Schmid et al.   Nature Reviews Rheumatology

2019 update of the EULAR recommendations for the management of systemic lupus erythematosus

(2019) Antonis Fanouriakis et al.   ANNALS OF THE RHEUMATIC DISEASES

Abatacept concentrations in maternal serum and breast milk during breastfeeding and an infant safety assessment: a case study

(2019) Jumpei Saito et al.   RHEUMATOLOGY

Tocilizumab during pregnancy and lactation: drug levels in maternal serum, cord blood, breast milk and infant serum

(2019) Jumpei Saito et al.   RHEUMATOLOGY

Placental transfer of tocilizumab in a patient with rheumatoid arthritis

(2019) Yoshifumi Tada et al.   RHEUMATOLOGY

The Extended Use of Eculizumab in Pregnancy and Complement Activation–Associated Diseases Affecting Maternal, Fetal and Neonatal Kidneys-The Future Is Now?

(2019) Vedran Stefanovic   Journal of Clinical Medicine

The longitudinal effect of biologic use on patient outcomes (disease activity, function, and disease severity) within a rheumatoid arthritis registry

(2019) Nancy A. Shadick et al.   CLINICAL RHEUMATOLOGY

Stratifying management of rheumatic disease for pregnancy and breastfeeding

(2019) Ian Giles et al.   Nature Reviews Rheumatology

The Neonatal Fc Receptor (FcRn): A Misnomer?

(2019) Michal Pyzik et al.   Frontiers in Immunology

#20 Anakinra use during pregnancy and lactation: A case report

(2019) Nesrin Çağlayan Duman et al.   REPRODUCTIVE TOXICOLOGY

Unexpectedly lower proportion of placental transferred tocilizumab relative to whole immunoglobulin G: a case report

(2019) M Moriyama et al.   SCANDINAVIAN JOURNAL OF RHEUMATOLOGY

EULAR recommendations for the management of Sjögren’s syndrome with topical and systemic therapies

(2019) Manuel Ramos-Casals et al.   ANNALS OF THE RHEUMATIC DISEASES

Exposure to Infliximab During Pregnancy: Post-Marketing Experience

(2019) Anja Geldhof et al.   DRUG SAFETY

Pregnancy Outcomes Reported During the 13-Year TREAT Registry: A Descriptive Report

(2018) Gary R. Lichtenstein et al.   AMERICAN JOURNAL OF GASTROENTEROLOGY

Continuous Anti-TNFα Use Throughout Pregnancy: Possible Complications For the Mother But Not for the Fetus. A Retrospective Cohort on the French National Health Insurance Database (EVASION)

(2018) Maxime Luu et al.   AMERICAN JOURNAL OF GASTROENTEROLOGY

Expression of FcRn receptor in placental tissue and its relationship with IgG levels in term and preterm newborns

(2018) Natalia A. Lozano et al.   AMERICAN JOURNAL OF REPRODUCTIVE IMMUNOLOGY

Lymphocyte changes and vaccination response in a child exposed to belimumab during pregnancy

(2018) Helle Bitter et al.   ANNALS OF THE RHEUMATIC DISEASES

2018 update of the EULAR recommendations for the management of Behçet’s syndrome

(2018) Gulen Hatemi et al.   ANNALS OF THE RHEUMATIC DISEASES

Secukinumab in pregnancy: outcomes in psoriasis, psoriatic arthritis and ankylosing spondylitis from the global safety database

(2018) R. B. Warren et al.   BRITISH JOURNAL OF DERMATOLOGY

Use of Biologic Therapy by Pregnant Women With Inflammatory Bowel Disease Does Not Affect Infant Response to Vaccines

(2018) Dawn B. Beaulieu et al.   Clinical Gastroenterology and Hepatology

Exposure Concentrations of Infants Breastfed by Women Receiving Biologic Therapies for Inflammatory Bowel Diseases and Effects of Breastfeeding on Infections and Development

(2018) Rebecca Matro et al.   GASTROENTEROLOGY

P614 Pregnancy outcomes in women with IBD treated with biosimilar infliximab

(2018) M Kolar et al.   Journal of Crohns & Colitis

Hepatitis B Vaccination Effective in Children Exposed to Anti-Tumour Necrosis Factor Alpha in Utero

(2018) Alison de Lima et al.   Journal of Crohns & Colitis

Anti-TNF Levels in Cord Blood at Birth are Associated with Anti-TNF Type

(2018) Shannon L Kanis et al.   Journal of Crohns & Colitis

Five successful pregnancies with antenatal anakinra exposure

(2018) Chelsey J F Smith et al.   RHEUMATOLOGY

Ustekinumab Exposure during Conception and Pregnancy in Patients with Chronic Plaque Psoriasis - a case series of 10 pregnancies

(2018) N. Watson et al.   BRITISH JOURNAL OF DERMATOLOGY

Safety of Anti-TNF-Alpha Therapy During Pregnancy on Long-term Outcome of Exposed Children: A Controlled, Multicenter Observation

(2018) Dana Duricova et al.   INFLAMMATORY BOWEL DISEASES

Eculizumab in pregnancy: a narrative overview

(2018) Laura Sarno et al.   JOURNAL OF NEPHROLOGY

Safety of anti-rheumatic drugs in men trying to conceive: A systematic review and analysis of published evidence

(2018) Maria Mouyis et al.   SEMINARS IN ARTHRITIS AND RHEUMATISM

Disease activity assessment of rheumatic diseases during pregnancy: a comprehensive review of indices used in clinical studies

(2018) Laura Andreoli et al.   AUTOIMMUNITY REVIEWS

Systemic lupus erythematosus: Diagnosis and clinical management

(2018) Andrea Fava et al.   JOURNAL OF AUTOIMMUNITY

Eculizumab in a pregnant patient with laboratory onset of catastrophic antiphospholipid syndrome

(2018) Patrizia Rovere-Querini et al.   MEDICINE

Drug Safety and Risk of Adverse Outcomes for Pregnant Patients With Inflammatory Bowel Disease

(2017) Uma Mahadevan et al.   GASTROENTEROLOGY

Ustekinumab Drug Levels in Maternal and Cord Blood in a Woman With Crohn’s Disease Treated Until 33 Weeks of Gestation

(2017) Catherine R Rowan et al.   Journal of Crohns & Colitis

Use of Belimumab throughout 2 Consecutive Pregnancies in a Patient with Systemic Lupus Erythematosus

(2017) ANAND KUMTHEKAR et al.   JOURNAL OF RHEUMATOLOGY

Effect on mother and child of eculizumab given before caesarean section in a patient with severe antiphospholipid syndrome

(2017) Alice Gustavsen et al.   MEDICINE

Pregnancy and infant outcomes including major congenital malformations among women with chronic inflammatory arthritis or psoriasis, with and without etanercept use

(2017) Wendy J. Carman et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

OUP accepted manuscript

(2017)   RHEUMATOLOGY

International multi-centre study of pregnancy outcomes with interleukin-1 inhibitors

(2017) Taryn Youngstein et al.   RHEUMATOLOGY

Low level of Rituximab in human breast milk in a patient treated during lactation

(2017) Yngvill Bragnes et al.   RHEUMATOLOGY

Teriparatide and denosumab treatment for pregnancy and lactation-associated osteoporosis with multiple vertebral fractures: A case study

(2017) Akifumi Ijuin et al.   Taiwanese Journal of Obstetrics & Gynecology

IL-1-Blockade mit Anakinra in der Schwangerschaft

(2017) N. Venhoff et al.   ZEITSCHRIFT FUR RHEUMATOLOGIE

The use of biologics in pregnant patients with rheumatic disease

(2017) Monika Østensen   Expert Review of Clinical Pharmacology

Immunological Changes in Blood of Newborns Exposed to Anti-TNF-α during Pregnancy

(2017) Ana Esteve-Solé et al.   Frontiers in Immunology

Secukinumab: a review of the anti-IL-17A biologic for the treatment of psoriasis

(2017) Jillian Frieder et al.   Therapeutic Advances in Chronic Disease

Birth Outcomes in Children Fathered by Men Treated with Anti-TNF-α Agents Before Conception

(2016) Michael Due Larsen et al.   AMERICAN JOURNAL OF GASTROENTEROLOGY

FRI0176 Safety of anti-TNF Alfa Agents during Pregancy and Breastfeeding: Longterm Follow up of Exposed Children in A Case-Series of Mothers with Chronic Arthritides

(2016) F. Dall'ara et al.   ANNALS OF THE RHEUMATIC DISEASES

The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation

(2016) Carina Götestam Skorpen et al.   ANNALS OF THE RHEUMATIC DISEASES

EULAR/ERA-EDTA recommendations for the management of ANCA-associated vasculitis

(2016) M Yates et al.   ANNALS OF THE RHEUMATIC DISEASES

Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis

(2016) Gerd R Burmester et al.   ANNALS OF THE RHEUMATIC DISEASES

Low Risk of Birth Defects for Infants Whose Mothers Are Treated With Anti–Tumor Necrosis Factor Agents During Pregnancy

(2016) Gabriella Bröms et al.   Clinical Gastroenterology and Hepatology

Concentrations of Adalimumab and Infliximab in Mothers and Newborns, and Effects on Infection

(2016) Mette Julsgaard et al.   GASTROENTEROLOGY

Pregnancy outcomes of patients with paroxysmal nocturnal hemoglobinuria treated with eculizumab: a Japanese experience and updated review

(2016) Naoyuki Miyasaka et al.   INTERNATIONAL JOURNAL OF HEMATOLOGY

Safety of anti-rheumatic drugs for rheumatoid arthritis in pregnancy and lactation

(2016) Gene-Siew Ngian et al.   International Journal of Rheumatic Diseases

Certolizumab treatment during late pregnancy in patients with rheumatic diseases: Low drug levels in cord blood but possible risk for maternal infections. A case series of 13 patients

(2016) Frauke Förger et al.   JOINT BONE SPINE

Anti-Tumour Necrosis Factor α Therapies and Inflammatory Bowel Disease Pregnancy Outcomes: A Meta-analysis

(2016) Zaid Shihab et al.   Journal of Crohns & Colitis

Structural Basis for Eculizumab-Mediated Inhibition of the Complement Terminal Pathway

(2016) Janus Asbjørn Schatz-Jakobsen et al.   JOURNAL OF IMMUNOLOGY

Certolizumab pegol does not bind the neonatal Fc receptor (FcRn): Consequences for FcRn-mediated in vitro transcytosis and ex vivo human placental transfer

(2016) Charlene Porter et al.   JOURNAL OF REPRODUCTIVE IMMUNOLOGY

Therapeutic approach to IgG4-related disease

(2016) Pilar Brito-Zerón et al.   MEDICINE

Pregnancy outcomes after exposure to tocilizumab: A retrospective analysis of 61 patients in Japan

(2016) Ken Nakajima et al.   Modern Rheumatology

Materials and methods for delivery of biological drugs

(2016) Alexander N. Zelikin et al.   Nature Chemistry

Atypical haemolytic uraemic syndrome and pregnancy: outcome with ongoing eculizumab

(2016) Aude Servais et al.   NEPHROLOGY DIALYSIS TRANSPLANTATION

Pregnancy outcome after tocilizumab therapy in early pregnancy-a case series from the German Embryotox Pharmacovigilance Center

(2016) Corinna Weber-Schoendorfer et al.   REPRODUCTIVE TOXICOLOGY

BSR and BHPR guideline on prescribing drugs in pregnancy and breastfeeding—Part I: standard and biologic disease modifying anti-rheumatic drugs and corticosteroids: Table 1

(2016) Julia Flint et al.   RHEUMATOLOGY

Tocilizumab use in pregnancy: Analysis of a global safety database including data from clinical trials and post-marketing data

(2016) Maria Hoeltzenbein et al.   SEMINARS IN ARTHRITIS AND RHEUMATISM

Secukinumab for rheumatology: development and its potential place in therapy

(2016) Marije Koenders et al.   Drug Design Development and Therapy

A Snapshot on the On-Label and Off-Label Use of the Interleukin-1 Inhibitors in Italy among Rheumatologists and Pediatric Rheumatologists: A Nationwide Multi-Center Retrospective Observational Study

(2016) Antonio Vitale et al.   Frontiers in Pharmacology

Pregnancy outcome after TNF-α inhibitor therapy during the first trimester: a prospective multicentre cohort study

(2015) Corinna Weber-Schoendorfer et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Challenges in vaccinating infants born to mothers taking immunoglobulin biologicals during pregnancy

(2015) Juejing Ling et al.   Expert Review of Vaccines

Eculizumab treatment during pregnancy does not affect the complement system activity of the newborn

(2015) Randi Fykse Hallstensen et al.   IMMUNOBIOLOGY

Eculizumab in Pregnant Patients with Paroxysmal Nocturnal Hemoglobinuria

(2015) Richard J. Kelly et al.   NEW ENGLAND JOURNAL OF MEDICINE

Assessment of ixekizumab, an interleukin-17A monoclonal antibody, for potential effects on reproduction and development, including immune system function, in cynomolgus monkeys

(2015) D.O. Clarke et al.   REPRODUCTIVE TOXICOLOGY

EULAR recommendations for neuropsychiatric systemic lupus erythematosusvsusual care: results from two European centres

(2015) Cristina Pamfil et al.   RHEUMATOLOGY

Pregnancy outcomes following exposure to abatacept during pregnancy

(2015) Monica Kumar et al.   SEMINARS IN ARTHRITIS AND RHEUMATISM

Pregnancy outcome and safety of breast-feeding in two patients with paroxysmal nocturnal haemoglobinuria (PNH) treated with eculizumab

(2014) I Sarris et al.   Archives of Disease in Childhood-Fetal and Neonatal Edition

B Cell Suppression in Newborn Following Treatment of Pregnant Diffuse Large B-cell Lymphoma Patient with Rituximab Containing Regimen

(2014) Prakas Kumar Mandal et al.   INDIAN JOURNAL OF PEDIATRICS

Anti-TNFα Therapies Are Safe During Pregnancy in Women with Inflammatory Bowel Disease

(2014) Neeraj Narula et al.   INFLAMMATORY BOWEL DISEASES

Impact of Anti–Tumor Necrosis Factor Alpha Antibodies Administered to Pregnant Women With Inflammatory Bowel Disease on Long-term Outcome of Exposed Children

(2014) Martin Bortlik et al.   INFLAMMATORY BOWEL DISEASES

Anti-TNF therapy: past, present and future

(2014) C. Monaco et al.   INTERNATIONAL IMMUNOLOGY

Anti-TNF-  Therapy May Cause Neonatal Neutropenia

(2014) T. Guiddir et al.   PEDIATRICS

TNF-α inhibitors do not impair sperm quality in males with ankylosing spondylitis after short-term or long-term treatment

(2014) Mihaela C. Micu et al.   RHEUMATOLOGY

Use of belimumab throughout pregnancy to treat active systemic lupus erythematosus—A case report

(2014) Abhijeet Danve et al.   SEMINARS IN ARTHRITIS AND RHEUMATISM

Brief Report: Anakinra Use During Pregnancy in Patients With Cryopyrin-Associated Periodic Syndromes

(2014) Zenas Chang et al.   Arthritis & Rheumatology

Brief Report: No Excess Risks in Offspring With Paternal Preconception Exposure to Disease-Modifying Antirheumatic Drugs

(2014) Marianne Wallenius et al.   Arthritis & Rheumatology

Safety of Thiopurines and Anti-TNF-α Drugs During Pregnancy in Patients With Inflammatory Bowel Disease

(2013) M J Casanova et al.   AMERICAN JOURNAL OF GASTROENTEROLOGY

Reproductive toxicity of denosumab in cynomolgus monkeys

(2013) Jeanine L. Bussiere et al.   REPRODUCTIVE TOXICOLOGY

Pregnancy outcome following gestational exposure to TNF-alpha-inhibitors: A prospective, comparative, observational study

(2013) Orna Diav-Citrin et al.   REPRODUCTIVE TOXICOLOGY

Brief Report: Risk of Adverse Fetal Outcomes Associated With Immunosuppressive Medications for Chronic Immune-Mediated Diseases in Pregnancy

(2013) William O. Cooper et al.   Arthritis & Rheumatology

Rituximab in the treatment of refractory adult and juvenile dermatomyositis and adult polymyositis: A randomized, placebo-phase trial

(2012) Chester V. Oddis et al.   ARTHRITIS AND RHEUMATISM

The Effects of Interleukin-6 Signal Blockade on Fertility, Embryo-fetal Development, and Immunization In vivo

(2012) Takayuki Sakurai et al.   BIRTH DEFECTS RESEARCH PART B-DEVELOPMENTAL AND REPRODUCTIVE TOXICOLOGY

Placental Transfer of Anti–Tumor Necrosis Factor Agents in Pregnant Patients With Inflammatory Bowel Disease

(2012) Uma Mahadevan et al.   Clinical Gastroenterology and Hepatology

Abatacept therapy and safety management

(2012) Thao Pham et al.   JOINT BONE SPINE

Fertility in male patients with seronegative spondyloarthropathies treated with infliximab

(2012) Ioanna Saougou et al.   JOINT BONE SPINE

Discovery and mechanism of ustekinumab

(2012) Jacqueline M. Benson et al.   mAbs

Outcomes after anti-rheumatic drug use before and during pregnancy: a cohort study among 150 000 pregnant women and expectant fathers

(2012) KK Viktil et al.   SCANDINAVIAN JOURNAL OF RHEUMATOLOGY

TNF-α and the Development of the Neonatal Immune System: Implications for Inhibitor Use in Pregnancy

(2011) Razvan Arsenescu et al.   AMERICAN JOURNAL OF GASTROENTEROLOGY

Anti-TNF therapies and pregnancy: outcome of 130 pregnancies in the British Society for Rheumatology Biologics Register

(2011) S. M. M. Verstappen et al.   ANNALS OF THE RHEUMATIC DISEASES

Inflammatory Profile and Response to Anti-Tumor Necrosis Factor Therapy in Patients with Chronic Pulmonary Sarcoidosis

(2011) Matthew J. Loza et al.   Clinical and Vaccine Immunology

Outcome of pregnancy in women with inflammatory bowel disease treated with antitumor necrosis factor therapy

(2011) Fabian Schnitzler et al.   INFLAMMATORY BOWEL DISEASES

Detection of infliximab in breast milk of nursing mothers with inflammatory bowel disease

(2011) Shomron Ben-Horin et al.   Journal of Crohns & Colitis

The Distribution of Congenital Anomalies Within the VACTERL Association Among Tumor Necrosis Factor Antagonist-exposed Pregnancies Is Similar to the General Population

(2011) H. J. M. J. CRIJNS et al.   JOURNAL OF RHEUMATOLOGY

Patterns of medication use during pregnancy in rheumatoid arthritis

(2011) Bindee Kuriya et al.   ARTHRITIS CARE & RESEARCH

The London Position Statement of the World Congress of Gastroenterology on Biological Therapy for IBD With the European Crohn's and Colitis Organisation: Pregnancy and Pediatrics

(2010) Uma Mahadevan et al.   AMERICAN JOURNAL OF GASTROENTEROLOGY

The Immune System in Pregnancy: A Unique Complexity

(2010) Gil Mor et al.   AMERICAN JOURNAL OF REPRODUCTIVE IMMUNOLOGY

Pregnancy outcomes after maternal exposure to rituximab

(2010) E. F. Chakravarty et al.   BLOOD

The management of pregnancy in paroxysmal nocturnal haemoglobinuria on long term eculizumab

(2010) Richard Kelly et al.   BRITISH JOURNAL OF HAEMATOLOGY

Treatment of cancer during pregnancy with monoclonal antibodies: a real challenge

(2010) Hatem A Azim Jr et al.   Expert Review of Clinical Immunology

Case Report: Fatal case of disseminated BCG infection in an infant born to a mother taking infliximab for Crohn's Disease

(2010) Kuldeep Cheent et al.   Journal of Crohns & Colitis

Measuring Multiple Etanercept Levels in the Breast Milk of a Nursing Mother with Rheumatoid Arthritis

(2010) S. KEELING et al.   JOURNAL OF RHEUMATOLOGY

Etanercept concentrations in maternal serum, umbilical cord serum, breast milk and child serum during breastfeeding

(2010) B. G. Berthelsen et al.   RHEUMATOLOGY

Etanercept during pregnancy and lactation in a patient with rheumatoid arthritis: drug levels in maternal serum, cord blood, breast milk and the infant's serum

(2009) A Murashima et al.   ANNALS OF THE RHEUMATIC DISEASES

Clinical response, pharmacokinetics, development of human anti-chimaeric antibodies, and synovial tissue response to rituximab treatment in patients with rheumatoid arthritis

(2009) R M Thurlings et al.   ANNALS OF THE RHEUMATIC DISEASES

Epidemiological studies in incidence, prevalence, mortality, and comorbidity of the rheumatic diseases

(2009) Sherine E Gabriel et al.   ARTHRITIS RESEARCH & THERAPY

Placental Transport of Immunoglobulins: A Clinical Review for Gastroenterologists Who Prescribe Therapeutic Monoclonal Antibodies to Women During Conception and Pregnancy

(2008) Sunanda V Kane et al.   AMERICAN JOURNAL OF GASTROENTEROLOGY

Rituximab Administration in Third Trimester of Pregnancy Suppresses Neonatal B-Cell Development

(2008) D. T. Klink et al.   Clinical & Developmental Immunology

Effects of Administration of a Monoclonal Antibody against Mouse Tumor Necrosis Factor Alpha during Pregnancy and Lactation on the Pre- and Postnatal Development of the Mouse Immune System

(2008) Pauline L. Martin et al.   INTERNATIONAL JOURNAL OF TOXICOLOGY