Literature DB >> 23197028

Factors influencing non-approval of new drugs in Europe.

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.   

Abstract

Mesh：

Year:  2012        PMID： 23197028     DOI： 10.1038/nrd3894

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


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  2 in total

1.  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

Review 2.  How to improve R&D productivity: the pharmaceutical industry's grand challenge.

Authors:  Steven M Paul; Daniel S Mytelka; Christopher T Dunwiddie; Charles C Persinger; Bernard H Munos; Stacy R Lindborg; Aaron L Schacht
Journal:  Nat Rev Drug Discov       Date:  2010-02-19       Impact factor: 84.694
  2 in total
  7 in total

1.  Data informs debate.

Authors:  Elizabeth Roughead
Journal:  Aust Prescr       Date:  2015-04-01

2.  Observations on Three Endpoint Properties and Their Relationship to Regulatory Outcomes of European Oncology Marketing Applications.

Authors:  Lawrence Liberti; Pieter Stolk; James Neil McAuslane; Jan Schellens; Alasdair M Breckenridge; Hubert Leufkens
Journal:  Oncologist       Date:  2015-05-06

3.  Regulatory watch: Impact of scientific advice from the European Medicines Agency.

Authors:  Matthias P Hofer; Christina Jakobsson; Nikolaos Zafiropoulos; Spiros Vamvakas; Thorsten Vetter; Jan Regnstrom; Robert J Hemmings
Journal:  Nat Rev Drug Discov       Date:  2015-04-17       Impact factor: 84.694

4.  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

5.  Take Care of the Fast-in-Human Study.

Authors:  E-J van Hoogdalem
Journal:  Clin Transl Sci       Date:  2017-01-10       Impact factor: 4.689

6.  Efficacy gap between phase II and subsequent phase III studies in oncology.

Authors:  Rick A Vreman; Svetlana V Belitser; Ana T M Mota; Anke M Hövels; Wim G Goettsch; Kit C B Roes; Hubert G M Leufkens; Aukje K Mantel-Teeuwisse
Journal:  Br J Clin Pharmacol       Date:  2020-02-21       Impact factor: 4.335

7.  Associations between uncertainties identified by the European Medicines Agency and national decision making on reimbursement by HTA agencies.

Authors:  Lourens T Bloem; Rick A Vreman; Niels W L Peeters; Jarno Hoekman; Menno E van der Elst; Hubert G M Leufkens; Olaf H Klungel; Wim G Goettsch; Aukje K Mantel-Teeuwisse
Journal:  Clin Transl Sci       Date:  2021-05-01       Impact factor: 4.689
  7 in total

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