Literature DB >> 17631248

Preclinical and clinical safety of monoclonal antibodies.

Mohammad A Tabrizi1, Lorin K Roskos.   

Abstract

Owing to their unique specificity, monoclonal antibodies have provided a novel approach to the treatment of human diseases. Several types of antibodies against a diverse array of pharmacological targets have been marketed and many more are currently in clinical trials. Factors related to antigen expression, target pharmacology, and antibody effector functions can contribute to the adverse event profiles observed with monoclonal antibodies. Effective translation of information gained from preclinical research and safety studies into clinical development is a crucial step for successful development of monoclonal antibodies.

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Year:  2007        PMID: 17631248     DOI: 10.1016/j.drudis.2007.05.010

Source DB:  PubMed          Journal:  Drug Discov Today        ISSN: 1359-6446            Impact factor:   7.851


  25 in total

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Journal:  AAPS J       Date:  2012-03-10       Impact factor: 4.009

Review 2.  Application of quantitative pharmacology in development of therapeutic monoclonal antibodies.

Authors:  Mohammad Tabrizi; Cherryl Funelas; Hamza Suria
Journal:  AAPS J       Date:  2010-07-24       Impact factor: 4.009

Review 3.  Biologic agents in islet transplantation.

Authors:  Boris Gala-Lopez; Andrew R Pepper; A M James Shapiro
Journal:  Curr Diab Rep       Date:  2013-10       Impact factor: 4.810

4.  Preclinical development of monoclonal antibodies: considerations for the use of non-human primates.

Authors:  Kathryn Chapman; Nick Pullen; Lee Coney; Maggie Dempster; Laura Andrews; Jeffrey Bajramovic; Paul Baldrick; Lorrene Buckley; Abby Jacobs; Geoff Hale; Colin Green; Ian Ragan; Vicky Robinson
Journal:  MAbs       Date:  2009-09-30       Impact factor: 5.857

Review 5.  Surrogate end points in the design of immunotherapy trials: emerging lessons from type 1 diabetes.

Authors:  Bart O Roep; Mark Peakman
Journal:  Nat Rev Immunol       Date:  2010-02       Impact factor: 53.106

6.  Combined active and passive immunization against nicotine: minimizing monoclonal antibody requirements using a target antibody concentration strategy.

Authors:  Katherine E Cornish; Andrew C Harris; Mark G LeSage; Dan E Keyler; Danielle Burroughs; Cathy Earley; Paul R Pentel
Journal:  Int Immunopharmacol       Date:  2011-07-28       Impact factor: 4.932

7.  Use of pharmacokinetic/ pharmacodynamic modelling for starting dose selection in first-in-human trials of high-risk biologics.

Authors:  Balaji M Agoram
Journal:  Br J Clin Pharmacol       Date:  2008-12-11       Impact factor: 4.335

Review 8.  The pharmacokinetics and pharmacodynamics of denosumab in patients with advanced solid tumours and bone metastases: a systematic review.

Authors:  Winnie Sohn; Mary Ann Simiens; Kelly Jaeger; Shauna Hutton; Graham Jang
Journal:  Br J Clin Pharmacol       Date:  2014-09       Impact factor: 4.335

9.  A phase 1 study evaluating the pharmacokinetics, safety and tolerability of repeat dosing with a human IL-13 antibody (CAT-354) in subjects with asthma.

Authors:  Dave Singh; Binita Kane; Nestor A Molfino; Raffaella Faggioni; Lorin Roskos; Ashley Woodcock
Journal:  BMC Pulm Med       Date:  2010-01-08       Impact factor: 3.317

10.  Isolation and chimerization of a highly neutralizing antibody conferring passive protection against lethal Bacillus anthracis infection.

Authors:  Ronit Rosenfeld; Hadar Marcus; Einat Ben-Arie; Bat-El Lachmi; Adva Mechaly; Shaul Reuveny; Orit Gat; Ohad Mazor; Arie Ordentlich
Journal:  PLoS One       Date:  2009-07-24       Impact factor: 3.240

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