Literature DB >> 20431561

New drug approval success rate in Europe in 2009.

Hans-Georg Eichler1, Bo Aronsson, Eric Abadie, Tomas Salmonson.   

Abstract

Mesh：

Year:  2010        PMID： 20431561     DOI： 10.1038/nrd3169

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


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  4 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.  2009 FDA drug approvals.

Authors:  Bethan Hughes
Journal:  Nat Rev Drug Discov       Date:  2010-02       Impact factor: 84.694

Review 3.  Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma.

Authors:  Hans-Georg Eichler; Francesco Pignatti; Bruno Flamion; Hubert Leufkens; Alasdair Breckenridge
Journal:  Nat Rev Drug Discov       Date:  2008-09-12       Impact factor: 84.694

4.  Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency.

Authors:  Jan Regnstrom; Franz Koenig; Bo Aronsson; Tatiana Reimer; Kristian Svendsen; Stelios Tsigkos; Bruno Flamion; Hans-Georg Eichler; Spiros Vamvakas
Journal:  Eur J Clin Pharmacol       Date:  2009-11-20       Impact factor: 2.953
  4 in total
  12 in total

1.  Akt/GSK-3β/eNOS phosphorylation arbitrates safranal-induced myocardial protection against ischemia-reperfusion injury in rats.

Authors:  Saurabh Bharti; Mahaveer Golechha; Santosh Kumari; Khalid Mehmood Siddiqui; Dharamvir Singh Arya
Journal:  Eur J Nutr       Date:  2011-10-09       Impact factor: 5.614

2.  Post-approval safety issues with innovative drugs: a European cohort study.

Authors:  Peter G M Mol; Arna H Arnardottir; Domenico Motola; Patrick J Vrijlandt; Ruben G Duijnhoven; Flora M Haaijer-Ruskamp; Pieter A de Graeff; Petra Denig; Sabine M J M Straus
Journal:  Drug Saf       Date:  2013-11       Impact factor: 5.606

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  Disclosure of grounds of European withdrawn and refused applications: a step forward on regulatory transparency.

Authors:  Giovanni Tafuri; Francesco Trotta; Hubert G M Leufkens; Luca Pani
Journal:  Br J Clin Pharmacol       Date:  2013-04       Impact factor: 4.335

4.  Additional safety risk to exceptionally approved drugs in Europe?

Authors:  Arna H Arnardottir; Flora M Haaijer-Ruskamp; Sabine M J Straus; Hans-Georg Eichler; Pieter A de Graeff; Peter G M Mol
Journal:  Br J Clin Pharmacol       Date:  2011-09       Impact factor: 4.335

5.  Drug discovery: lessons from evolution.

Authors:  John Warren
Journal:  Br J Clin Pharmacol       Date:  2011-04       Impact factor: 4.335

Review 6.  Bridging the efficacy-effectiveness gap: a regulator's perspective on addressing variability of drug response.

Authors:  Hans-Georg Eichler; Eric Abadie; Alasdair Breckenridge; Bruno Flamion; Lars L Gustafsson; Hubert Leufkens; Malcolm Rowland; Christian K Schneider; Brigitte Bloechl-Daum
Journal:  Nat Rev Drug Discov       Date:  2011-07-01       Impact factor: 84.694

7.  Factors influencing non-approval of new drugs in Europe.

Authors:  Michelle Putzeist; Aukje K Mantel-Teeuwisse; Bo Aronsson; Malcolm Rowland; Christine C Gispen-de Wied; Spiros Vamvakas; Arno W Hoes; Hubert G M Leufkens; Hans-Georg Eichler
Journal:  Nat Rev Drug Discov       Date:  2012-12       Impact factor: 84.694

8.  Regulatory scientific advice in drug development: does company size make a difference?

Authors:  Michelle Putzeist; Aukje K Mantel-Teeuwisse; Christine C Gispen-De Wied; Arno W Hoes; Hubert G Leufkens
Journal:  Eur J Clin Pharmacol       Date:  2010-11-04       Impact factor: 2.953

9.  An analysis of marketing authorisation applications via the mutual recognition and decentralised procedures in Europe.

Authors:  Hans C Ebbers; Joris Langedijk; Jacoline C Bouvy; Jarno Hoekman; Wouter P C Boon; Jean Philippe de Jong; Marie L De Bruin
Journal:  Eur J Clin Pharmacol       Date:  2015-07-25       Impact factor: 2.953

Review 10.  Deficiencies in the transfer and availability of clinical trials evidence: a review of existing systems and standards.

Authors:  Gert van Valkenhoef; Tommi Tervonen; Bert de Brock; Hans Hillege
Journal:  BMC Med Inform Decis Mak       Date:  2012-09-04       Impact factor: 2.796
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