Literature DB >> 23738917

Challenges posed to the European pharmaceutical regulatory system by highly personalized medicines.

John D Johnston1, Peter Feldschreiber.   

Abstract

The European pharmaceutical regulatory system has not yet been challenged by issues related to highly personalized medicines such as those to be found with active substances that affect RNA biochemistry. We review the current status of RNA-based pharmacology and present three possible case histories. The implications for the European pharmaceutical regulatory system are discussed.
© 2013 The British Pharmacological Society.

Keywords:  Europe; RNA; antisense oligo-nucleotide; highly personalized medicine; pharmaceutical regulation

Mesh：

Substances：

Year:  2014        PMID： 23738917      PMCID： PMC3952717          DOI： 10.1111/bcp.12173

Source DB:  PubMed          Journal:  Br J Clin Pharmacol        ISSN： 0306-5251            Impact factor:   4.335


  7 in total

1.  Concepts to automate the theoretical design of effective antisense oligonucleotides.

Authors:  R K Far; W Nedbal; G Sczakiel
Journal:  Bioinformatics       Date:  2001-11       Impact factor: 6.937

Review 2.  RNA-based therapeutics: current progress and future prospects.

Authors:  John C Burnett; John J Rossi
Journal:  Chem Biol       Date:  2012-01-27

3.  The risks of therapeutic misconception and individual patient (n=1) "trials" in rare diseases such as Duchenne dystrophy.

Authors:  Annemieke Aartsma-Rus
Journal:  Neuromuscul Disord       Date:  2010-11-03       Impact factor: 4.296

Review 4.  Antisense oligonucleotides: from design to therapeutic application.

Authors:  Jasmine H P Chan; Shuhui Lim; W S Fred Wong
Journal:  Clin Exp Pharmacol Physiol       Date:  2006 May-Jun       Impact factor: 2.557

5.  Guidelines for antisense oligonucleotide design and insight into splice-modulating mechanisms.

Authors:  Annemieke Aartsma-Rus; Laura van Vliet; Marscha Hirschi; Anneke A M Janson; Hans Heemskerk; Christa L de Winter; Sjef de Kimpe; Judith C T van Deutekom; Peter A C 't Hoen; Gert-Jan B van Ommen
Journal:  Mol Ther       Date:  2008-09-23       Impact factor: 11.454

Review 6.  Biological barriers to therapy with antisense and siRNA oligonucleotides.

Authors:  R Juliano; J Bauman; H Kang; X Ming
Journal:  Mol Pharm       Date:  2009 May-Jun       Impact factor: 4.939

Review 7.  RNA therapeutics: beyond RNA interference and antisense oligonucleotides.

Authors:  Ryszard Kole; Adrian R Krainer; Sidney Altman
Journal:  Nat Rev Drug Discov       Date:  2012-01-20       Impact factor: 84.694
  7 in total
  1 in total

Review 1.  Proposal for new European pharmaceutical legislation to permit access to custom-made anti-sense oligonucleotide medicinal products.

Authors:  John D Johnston; Peter Feldschreiber
Journal:  Br J Clin Pharmacol       Date:  2014-06       Impact factor: 4.335
  1 in total

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