Literature DB >> 22891872

Disclosure of grounds of European withdrawn and refused applications: a step forward on regulatory transparency.

Giovanni Tafuri, Francesco Trotta, Hubert G M Leufkens, Luca Pani.   

Abstract

Mesh：

Year:  2013        PMID： 22891872      PMCID： PMC3612734          DOI： 10.1111/j.1365-2125.2012.04424.x

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


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  5 in total

1.  The review of drug applications submitted to the European Medicines Evaluation Agency: frequently raised objections, and outcome.

Authors:  Francesco Pignatti; Bo Aronsson; Nick Gate; Spiros Vamvakas; George Wade; Isabelle Moulon; Patrick Le Courtois
Journal:  Eur J Clin Pharmacol       Date:  2002-11-13       Impact factor: 2.953

2.  New drug approval success rate in Europe in 2009.

Authors:  Hans-Georg Eichler; Bo Aronsson; Eric Abadie; Tomas Salmonson
Journal:  Nat Rev Drug Discov       Date:  2010-05       Impact factor: 84.694

3.  Transparency at the Food and Drug Administration.

Authors:  Afia K Asamoah; Joshua M Sharfstein
Journal:  N Engl J Med       Date:  2010-05-19       Impact factor: 91.245

4.  Europe's opportunity to open up drug regulation.

Authors:  Silvio Garattini; Vittorio Bertele'
Journal:  BMJ       Date:  2010-03-30

5.  European Medicines Agency--more transparency needed.

Authors: 
Journal:  Lancet       Date:  2010-05-22       Impact factor: 79.321
  5 in total
  5 in total

Review 1.  Regulating prescription drugs for patient safety: does Bill C-17 go far enough?

Authors:  Matthew Herder; Elaine Gibson; Janice Graham; Joel Lexchin; Barbara Mintzes
Journal:  CMAJ       Date:  2014-03-10       Impact factor: 8.262

2.  Comparison of a teratogenic transcriptome-based predictive test based on human embryonic versus inducible pluripotent stem cells.

Authors:  Vaibhav Shinde; Sureshkumar Perumal Srinivasan; Margit Henry; Tamara Rotshteyn; Jürgen Hescheler; Jörg Rahnenführer; Marianna Grinberg; Johannes Meisig; Nils Blüthgen; Tanja Waldmann; Marcel Leist; Jan Georg Hengstler; Agapios Sachinidis
Journal:  Stem Cell Res Ther       Date:  2016-12-30       Impact factor: 6.832

Review 3.  Cardiotoxicity and Heart Failure: Lessons from Human-Induced Pluripotent Stem Cell-Derived Cardiomyocytes and Anticancer Drugs.

Authors:  Agapios Sachinidis
Journal:  Cells       Date:  2020-04-17       Impact factor: 6.600

4.  Recognizing that Evidence is Made, not Born.

Authors:  Robyn Lim; David K Lee; Pierre Sabourin; John Ferguson; Marilyn Metcalf; Meredith Smith; Solange Corriol-Rohou; Hans-Georg Eichler; Murray Lumpkin; Gigi Hirsch; Inhua Muijrers Chen; Brian O'Rourke; Anja Schiel; Nick Crabb; Naomi Aronson; Edmund Pezalla; Marc Boutin; Louise Binder; Linda Wilhelm
Journal:  Clin Pharmacol Ther       Date:  2019-01-04       Impact factor: 6.875

5.  Identification of genomic biomarkers for anthracycline-induced cardiotoxicity in human iPSC-derived cardiomyocytes: an in vitro repeated exposure toxicity approach for safety assessment.

Authors:  Umesh Chaudhari; Harshal Nemade; Vilas Wagh; John Antonydas Gaspar; James K Ellis; Sureshkumar Perumal Srinivasan; Dimitry Spitkovski; Filomain Nguemo; Jochem Louisse; Susanne Bremer; Jürgen Hescheler; Hector C Keun; Jan G Hengstler; Agapios Sachinidis
Journal:  Arch Toxicol       Date:  2015-11-04       Impact factor: 5.153
  5 in total

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