Immune-Mediated Liver Effects Associated With Administration of a Human Anti-IL-21 Receptor Antibody (ATR-107) in Rats.

Autor: Hu W; Pfizer Inc., San Diego, California, USA.; Vividion Therapeutics, San Diego, California, USA., Buetow BS; Pfizer Inc., San Diego, California, USA., Sachdeva K; Wyeth, Chazy, New York, USA., Leach MW; Pfizer Inc., Cambridge, Massachusetts, USA.; Trident Toxicology, Inc., Shrewsbury, Massachusetts, USA.

Publikováno v: Toxicologic pathology [Toxicol Pathol] 2024 Jul; Vol. 52 (5), pp. 232-250. Date of Electronic Publication: 2024 Jul 25.

Recommendations to improve the patient experience and avoid bias when prenatal screening/testing.

Autor: Meredith S; Human Development Institute, University of Kentucky, USA. Electronic address: Stephanie.meredith@uky.edu., Brackett S; Children's Mercy Hospital in Kansas City, MO, USA., Diaz KM; Columbia University Medical Center, USA., Freeman KG; New Jersey Regional Family Planning Council, USA., Huggins E; Duke University School of Medicine, Department of Pediatrics, USA., Khan H; Autism Society Greater Cincinnati, USA., Leach MW; Human Development Institute, University of Kentucky, USA., Levitz M; Human Development Institute, University of Kentucky, USA., Michie M; CaseWestern Reserve School of Medicine, Department of Bioethics, USA., Onufer J; The Boggs Center on Developmental Disabilities, Rutgers Robert Wood Johnson Medical School, USA., Skotko BG; Down Syndrome Program, Division of Medical Genetics and Metabolism, Department of Pediatrics, Massachusetts General Hospital, USA; Department of Pediatrics, Harvard Medical School, USA., Smith L; Center for Dignity in Healthcare for People with Disabilities, USA., Nicole White A; Cincinnati Children's Hospital, USA., Waller T; Kennedy Krieger Institute and Maryland Center for Developmental Disabilities, USA., Ayers K; Cincinnati Children's Hospital, USA.

Publikováno v: Disability and health journal [Disabil Health J] 2023 Apr; Vol. 16 (2), pp. 101401. Date of Electronic Publication: 2022 Nov 05.

Re-evaluating the need for chronic toxicity studies with therapeutic monoclonal antibodies, using a weight of evidence approach.

Autor: Chien HT; Medicines Evaluation Board, Utrecht, the Netherlands; Radboud University Medical Center, Nijmegen, the Netherlands., Prior H; National Centre for the Replacement Refinement & Reduction of Animals in Research (NC3Rs), London, UK., Andrews L; AbbVie, Worcester, MA, USA., van Aerts L; Medicines Evaluation Board, Utrecht, the Netherlands., Cauvin A; UCB BioPharma, Brussels, Belgium., Clarke DO; Lilly Corporate Center, Indianapolis, IN, USA., Datta K; Bristol Myers Squibb, Nonclinical Research and Development, New Jersey, USA., Dempster M; GlaxoSmithKline, King of Prussia, PA, USA., Dybdal N; Genentech, South San Francisco, CA, USA., Freebern W; Janssen Inc., Spring House, PA, USA., de Haan L; ADC Therapeutics, I-HUB, Imperial College White City Campus, London, UK., Herzyk D; Merck & Co., Inc., West Point, PA, USA., Hey A; AstraZeneca, Cambridge, UK., Kissner T; Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany., Kronenberg S; Roche Pharmaceutical Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center Basel, Switzerland., Leach MW; Pfizer Inc., Cambridge, MA, USA., Lee D; Genentech, South San Francisco, CA, USA., Schutte K; European Commission, Brussels, Belgium., Sewell F; National Centre for the Replacement Refinement & Reduction of Animals in Research (NC3Rs), London, UK., Trouba K; Janssen Inc., Spring House, PA, USA., Ulrich P; Novartis Institutes for BioMedical Research, Basel, Switzerland., Weir L; GlaxoSmithKline, Ware, Hertfordshire, UK., van Meer P; Medicines Evaluation Board, Utrecht, the Netherlands. Electronic address: p.v.meer@cbg-meb.nl.

Publikováno v: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2023 Feb; Vol. 138, pp. 105329. Date of Electronic Publication: 2022 Dec 30.

Strategies and Recommendations for Using a Data-Driven and Risk-Based Approach in the Selection of First-in-Human Starting Dose: An International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) Assessment.

Autor: Leach MW; Drug Safety Research and Development, Pfizer, Inc., Cambridge, Massachusetts, USA., Clarke DO; Nonclinical Safety Assessment, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA., Dudal S; DMPK Project Leads and Translational M&S, Pharmaceutical Sciences, F. Hoffmann-La Roche Ltd., Basel, Switzerland., Han C; Biologics Development Sciences, Janssen Research and Development, LLC, Spring House, Pennsylvania, USA., Li C; Department of Clinical Pharmacology, Genentech, Inc., South San Francisco, California, USA., Yang Z; Metabolism and Pharmacokinetics, Bristol-Myers Squibb Co., Princeton, New Jersey, USA., Brennan FR; Non-Clinical Safety, UCB Pharma, Slough, UK., Bailey WJ; Safety Assessment and Laboratory Animal Resources, Merck & Co., Inc., West Point, Pennsylvania, USA., Chen Y; Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Boston, Massachusetts, USA., Deslandes A; Translational Medicine & Early Development, Sanofi R&D, Centre de Recherche Vitry-sur-Seine 13, Vitry-sur-Seine Cedex, France., Loberg LI; Preclinical Safety, AbbVie, North Chicago, Illinois, USA., Mayawala K; Quantitative Pharmacology and Pharmacometrics, PPDM, Merck & Co., Inc., Kenilworth, New Jersey, USA., Rogge MC; Quantitative and Translational Science, Takeda Pharmaceuticals, Cambridge, Massachusetts, USA., Todd M; Drug Safety Research and Development, Pfizer, Inc., San Diego, California, USA., Chemuturi NV; Pharmacokinetic Sciences, Novartis Institute of BioMedical Research, Inc., Cambridge, Massachusetts, USA.

Publikováno v: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2021 Jun; Vol. 109 (6), pp. 1395-1415. Date of Electronic Publication: 2020 Nov 03.

Classic and evolving approaches to evaluating cross reactivity of mAb and mAb-like molecules - A survey of industry 2008-2019.

Autor: MacLachlan TK; Novartis Institutes for Biomedical Research, Cambridge, MA, 01239, USA. Electronic address: Timothy.maclachlan@novartis.com., Price S; Charles River Laboratories, 15 Worman's Mill Court, Suite I, Frederick, MD, 21701, USA., Cavagnaro J; Access BIO, LC, Boyce, VA, 22620, USA., Andrews L; AbbVie, 100 Research Dr, Worcester, MA, 01520, USA., Blanset D; Boehringer Ingelheim, 900 Ridgebury Road, Ridgefield, CT, 06877, USA., Cosenza ME; MEC Regulatory & Toxicology Consulting, LLC, Moorpark, CA, 93021, USA., Dempster M; GlaxoSmithKline, 1250 South Collegeville Rd, Collegeville, PA, 19426, USA., Galbreath E; Drug Safety Research and Evaluation, Takeda US, Inc., Cambridge, MA, USA., Giusti AM; Roche Pharma Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center Zurich, Switzerland., Heinz-Taheny KM; Toxicology and Pathology, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA., Fleurance R; UCB BioPharma SRL, B-1420, Braine L'Alleud, Belgium., Sutter E; Novartis Institutes for Biomedical Research, Basel, Switzerland., Leach MW; Drug Safety Research and Development, Pfizer, Inc, 300 Technology Square, Cambridge, MA, 02139, USA.

Publikováno v: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2021 Apr; Vol. 121, pp. 104872. Date of Electronic Publication: 2021 Jan 22.