Literature DB >> 12119749

Preclinical safety evaluation of biotechnology-derived pharmaceuticals.

Joy A Cavagnaro1.   

Abstract

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Year:  2002        PMID： 12119749     DOI： 10.1038/nrd822

Source DB:  PubMed          Journal:  Nat Rev Drug Discov        ISSN： 1474-1776            Impact factor:   84.694


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  12 in total

1.  A cohort study exploring determinants of safety-related regulatory actions for biopharmaceuticals.

Authors:  Hans C Ebbers; Aukje K Mantel-Teeuwisse; Ellen H M Moors; Fakhredin A Sayed Tabatabaei; Huub Schellekens; Hubert G M Leufkens
Journal:  Drug Saf       Date:  2012-05-01       Impact factor: 5.606

2.  Biological therapies: concepts and challenges.

Authors:  Markus Müller
Journal:  Wien Klin Wochenschr       Date:  2006-09       Impact factor: 1.704

Review 3.  Immunotoxicity of monoclonal antibodies.

Authors:  Jacques Descotes
Journal:  MAbs       Date:  2009-03-19       Impact factor: 5.857

4.  Human interleukin-10 delivered intrathecally by self-complementary adeno-associated virus 8 induces xenogeneic transgene immunity without clinical neurotoxicity in swine.

Authors:  Mark D Unger; Josef Pleticha; Lukas F Heilmann; Laura K Newman; Timothy P Maus; Andreas S Beutler
Journal:  J Gene Med       Date:  2018-06-15       Impact factor: 4.565

5.  siRNA Therapeutics in Ocular Diseases.

Authors:  Javier Moreno-Montañés; Anne-Marie Bleau; Tamara Martínez; Beatriz Vargas; María Victoria González; Ana Isabel Jiménez
Journal:  Methods Mol Biol       Date:  2021

6.  Choice of Starting Dose for Biopharmaceuticals in First-in-Human Phase I Cancer Clinical Trials.

Authors:  Aaron R Hansen; Natalie Cook; M Stacey Ricci; Albiruni Razak; Christophe Le Tourneau; Kathleen McKeever; Lorin Roskos; Rakesh Dixit; Lillian L Siu; Mary Jane Hinrichs
Journal:  Oncologist       Date:  2015-05-11

7.  Toxicology and drug delivery by cucurbit[n]uril type molecular containers.

Authors:  Gaya Hettiarachchi; Duc Nguyen; Jing Wu; Derick Lucas; Da Ma; Lyle Isaacs; Volker Briken
Journal:  PLoS One       Date:  2010-05-06       Impact factor: 3.240

Review 8.  Applicability of predictive toxicology methods for monoclonal antibody therapeutics: status Quo and scope.

Authors:  Arathi Kizhedath; Simon Wilkinson; Jarka Glassey
Journal:  Arch Toxicol       Date:  2016-10-20       Impact factor: 5.153

Review 9.  Are innovation and new technologies in precision medicine paving a new era in patients centric care?

Authors:  Attila A Seyhan; Claudio Carini
Journal:  J Transl Med       Date:  2019-04-05       Impact factor: 5.531

Review 10.  Regulatory considerations for developing a phase I investigational new drug application for autologous induced pluripotent stem cells-based therapy product.

Authors:  Balendu Shekhar Jha; Mitra Farnoodian; Kapil Bharti
Journal:  Stem Cells Transl Med       Date:  2020-09-18       Impact factor: 6.940
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