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Akademický článek

Are Repeat-Dose Toxicity Studies Informative for Safety Assessment of Vaccine Candidates? A Survey of Vaccine Developers.

Autor: Rohde CM; Drug Safety Research and Development, Pfizer Worldwide Research, Development & Medicine, Pearl River, NY, USA., Destexhe E; Vaccine Toxicology Center of Excellence, GSK Vaccines R&D, Rixensart, Belgium., van der Laan JW; Section on Pharmacology, Toxicology and Kinetics, Medicines Evaluation Board, Utrecht, The Netherlands., Gould S; Charles River Laboratories, Evreux, France., Coe R; AgencyIQ by POLITICO, Washington, DC, USA., Haenen B; Preclinical Sciences and Translational Safety, JnJ Innovative Medicine, Janssen R&D LLC, A Johnson & Johnson Company, Beerse, Belgium.

Publikováno v: International journal of toxicology [Int J Toxicol] 2024 Oct 30, pp. 10915818241293371. Date of Electronic Publication: 2024 Oct 30.

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Akademický článek

Preclinical immunogenicity and safety of hemagglutinin-encoding modRNA influenza vaccines.

Autor: Hauguel T; Vaccine Research and Development, Pfizer Inc., Pearl River, NY, USA., Sharma A; Drug Safety Research & Development, Pfizer Inc., Pearl River, NY, USA., Mastrocola E; Vaccine Research and Development, Pfizer Inc., Pearl River, NY, USA., Lowry S; Vaccine Research and Development, Pfizer Inc., Pearl River, NY, USA., Maddur MS; Vaccine Research and Development, Pfizer Inc., Pearl River, NY, USA., Hu CH; Vaccine Research and Development, Pfizer Inc., Pearl River, NY, USA., Rajput S; Vaccine Research and Development, Pfizer Inc., Pearl River, NY, USA., Vitsky A; Drug Safety Research & Development, Pfizer Inc., La Jolla, CA, USA., Choudhary S; Drug Safety Research & Development, Pfizer Inc., Pearl River, NY, USA., Manickam B; Drug Safety Research & Development, Pfizer Inc., Groton, CT, USA., De Souza I; Vaccine Research and Development, Pfizer Inc., Pearl River, NY, USA., Chervona Y; Drug Safety Research & Development, Pfizer Inc., Pearl River, NY, USA., Moreno RM; Vaccine Research and Development, Pfizer Inc., Pearl River, NY, USA., Abdon C; Vaccine Research and Development, Pfizer Inc., Pearl River, NY, USA., Falcao L; Vaccine Research and Development, Pfizer Inc., Pearl River, NY, USA., Tompkins K; Vaccine Research and Development, Pfizer Inc., Pearl River, NY, USA., Illenberger D; Vaccine Research and Development, Pfizer Inc., Pearl River, NY, USA., Smith R; Vaccine Research and Development, Pfizer Inc., Pearl River, NY, USA., Meng F; Vaccine Research and Development, Pfizer Inc., Pearl River, NY, USA., Shi S; Vaccine Research and Development, Pfizer Inc., Pearl River, NY, USA., Efferen KS; Vaccine Research and Development, Pfizer Inc., Pearl River, NY, USA., Markiewicz V; Drug Safety Research & Development, Pfizer Inc., Groton, CT, USA., Umemoto C; Vaccine Research and Development, Pfizer Inc., Pearl River, NY, USA., Hu J; Global Biometrics & Data Management, Pfizer Inc., Collegeville, PA, USA., Chen W; Vaccine Research and Development, Pfizer Inc., Pearl River, NY, USA., Scully I; Vaccine Research and Development, Pfizer Inc., Pearl River, NY, USA., Rohde CM; Drug Safety Research & Development, Pfizer Inc., Pearl River, NY, USA., Anderson AS; Vaccine Research and Development, Pfizer Inc., Pearl River, NY, USA., Suphaphiphat Allen P; Vaccine Research and Development, Pfizer Inc., Pearl River, NY, USA. Pirada.Allen@pfizer.com.

Publikováno v: NPJ vaccines [NPJ Vaccines] 2024 Oct 07; Vol. 9 (1), pp. 183. Date of Electronic Publication: 2024 Oct 07.

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Akademický článek

Discovery and development of COVID-19 vaccines and therapeutics: nonclinical perspectives.

Autor: Khan N; Pfizer Research and Development, Pfizer Inc, Groton, CT, USA., Sathish J; Pfizer Research and Development, Pfizer Inc, Pearl River, NY, USA., Rohde CM; Pfizer Research and Development, Pfizer Inc, Pearl River, NY, USA.

Publikováno v: The Journal of toxicological sciences [J Toxicol Sci] 2024; Vol. 49 (3), pp. 79-94.

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Akademický článek

Toxicological Assessments of a Pandemic COVID-19 Vaccine-Demonstrating the Suitability of a Platform Approach for mRNA Vaccines.

Autor: Rohde CM; Drug Safety Research and Development, Pfizer Worldwide Research, Development & Medical, Pfizer, Inc., Pearl River, NY 10965, USA., Lindemann C; BioNTech SE, 55131 Mainz, Germany., Giovanelli M; Drug Safety Research and Development, Pfizer Worldwide Research, Development & Medical, Pfizer, Inc., Groton, CT 06340, USA., Sellers RS; Department of Pathology and Laboratory Medicine, University of North Carolina, Chapel Hill, NC 27599, USA., Diekmann J; BioNTech SE, 55131 Mainz, Germany., Choudhary S; Drug Safety Research and Development, Pfizer Worldwide Research, Development & Medical, Pfizer, Inc., Pearl River, NY 10965, USA., Ramaiah L; Drug Safety Research and Development, Pfizer Worldwide Research, Development & Medical, Pfizer, Inc., Pearl River, NY 10965, USA., Vogel AB; BioNTech SE, 55131 Mainz, Germany., Chervona Y; Drug Safety Research and Development, Pfizer Worldwide Research, Development & Medical, Pfizer, Inc., Pearl River, NY 10965, USA., Muik A; BioNTech SE, 55131 Mainz, Germany., Sahin U; BioNTech SE, 55131 Mainz, Germany.

Publikováno v: Vaccines [Vaccines (Basel)] 2023 Feb 11; Vol. 11 (2). Date of Electronic Publication: 2023 Feb 11.

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Akademický článek

COVID-19 Therapeutics and Vaccines: A Race to Save Lives.

Autor: Bebenek I; US Food and Drug Administration, Silver Spring, Maryland 20993, USA., Bannister R; Gilead Sciences, Inc., Foster City, California 94404, USA., Dubinion J; US Food and Drug Administration, Silver Spring, Maryland 20993, USA., Fortin M; Rutgers University, New Brunswick, New Jersey 08901, USA., Liu M; Regeneron Pharmaceuticals, Terrytown, New York 10591, USA., Motter AL; US Food and Drug Administration, Silver Spring, Maryland 20993, USA., Rohde CM; Pfizer, Pearl River, New York 10965, USA., Wrzesinski C; US Food and Drug Administration, Silver Spring, Maryland 20993, USA.

Publikováno v: Toxicological sciences : an official journal of the Society of Toxicology [Toxicol Sci] 2022 Jan 24; Vol. 185 (2), pp. 119-127.

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Akademický článek

Lack of effects on female fertility and prenatal and postnatal offspring development in rats with BNT162b2, a mRNA-based COVID-19 vaccine.

Autor: Bowman CJ; Drug Safety Research and Development, Pfizer Worldwide Research, Development & Medical, Groton, CT, USA. Electronic address: christopher.j.bowman@pfizer.com., Bouressam M; Charles River Laboratories France Safety Assessmsent SAS, Lyon, France., Campion SN; Drug Safety Research and Development, Pfizer Worldwide Research, Development & Medical, Groton, CT, USA., Cappon GD; Drug Safety Research and Development, Pfizer Worldwide Research, Development & Medical, Groton, CT, USA., Catlin NR; Drug Safety Research and Development, Pfizer Worldwide Research, Development & Medical, Groton, CT, USA., Cutler MW; Vaccine Research and Development, Pfizer Worldwide Research, Development & Medical, Pearl River, NY, USA., Diekmann J; Non-Clinical Safety, BioNTech SE, Mainz, Germany., Rohde CM; Drug Safety Research and Development, Pfizer Worldwide Research, Development & Medical, Pearl River, NY, USA., Sellers RS; Drug Safety Research and Development, Pfizer Worldwide Research, Development & Medical, Pearl River, NY, USA., Lindemann C; Non-Clinical Safety, BioNTech SE, Mainz, Germany.

Publikováno v: Reproductive toxicology (Elmsford, N.Y.) [Reprod Toxicol] 2021 Aug; Vol. 103, pp. 28-35. Date of Electronic Publication: 2021 May 28.

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