Literature DB >> 25877216

Adaptive licensing and facilitated regulatory pathways: A survey of stakeholder perceptions.

L Liberti1,2, P Stolk2, N McAuslane1, A Somauroo1, A M Breckenridge3, H G M Leufkens2.   

Abstract

Mesh：

Year:  2015        PMID： 25877216     DOI： 10.1002/cpt.140

Source DB:  PubMed          Journal:  Clin Pharmacol Ther        ISSN： 0009-9236            Impact factor:   6.875


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  4 in total

1.  Accelerated approval of medicines: fit for purpose?

Authors:  Alasdair Breckenridge; Lawrence Liberti
Journal:  Nat Rev Drug Discov       Date:  2018-01-05       Impact factor: 84.694

2.  The Qualitative Value of Facilitated Regulatory Pathways in Europe, USA, and Japan: Benefits, Barriers to Utilization, and Suggested Solutions.

Authors:  Magdalena Bujar; Neil McAuslane; Lawrence Liberti
Journal:  Pharmaceut Med       Date:  2021-02-04

3.  Type and Extent of Information on (Potentially Critical) Quality Attributes Described in European Public Assessment Reports for Adalimumab Biosimilars.

Authors:  Ali M Alsamil; Thijs J Giezen; Toine C Egberts; Hubert G Leufkens; Helga Gardarsdottir
Journal:  Pharmaceuticals (Basel)       Date:  2021-02-25

4.  Weighing of Evidence by Health Technology Assessment Bodies: Retrospective Study of Reimbursement Recommendations for Conditionally Approved Drugs.

Authors:  Rick A Vreman; Jacoline C Bouvy; Lourens T Bloem; Anke M Hövels; Aukje K Mantel-Teeuwisse; Hubert G M Leufkens; Wim G Goettsch
Journal:  Clin Pharmacol Ther       Date:  2018-11-08       Impact factor: 6.875
  4 in total

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