Literature DB >> 27806239

First-in-Human Clinical Trials - What We Can Learn from Tragic Failures.

Sergio Bonini1, Guido Rasi1.   

Abstract

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Mesh：

Year:  2016        PMID： 27806239     DOI： 10.1056/NEJMe1609006

Source DB:  PubMed          Journal:  N Engl J Med        ISSN： 0028-4793            Impact factor:   91.245


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  6 in total

1.  Consider drug efficacy before first-in-human trials.

Authors:  Jonathan Kimmelman; Carole Federico
Journal:  Nature       Date:  2017-01-30       Impact factor: 49.962

2.  Commentary on the EMA Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products.

Authors:  Joop van Gerven; Milton Bonelli
Journal:  Br J Clin Pharmacol       Date:  2018-05-30       Impact factor: 4.335

3.  Gating the holes in the Swiss cheese (part I): Expanding professor Reason's model for patient safety.

Authors:  Shashi S Seshia; G Bryan Young; Michael Makhinson; Preston A Smith; Kent Stobart; Pat Croskerry
Journal:  J Eval Clin Pract       Date:  2017-11-23       Impact factor: 2.431

Review 4.  Reviewing the role of healthy volunteer studies in drug development.

Authors:  Joyson J Karakunnel; Nam Bui; Latha Palaniappan; Keith T Schmidt; Kenneth W Mahaffey; Briggs Morrison; William D Figg; Shivaani Kummar
Journal:  J Transl Med       Date:  2018-12-04       Impact factor: 5.531

5.  European Federation for Exploratory Medicines Development Lyon Conference 2019: The Changing Landscape of Early Medicines Development-Be Prepared.

Authors:  Tim Hardman; Henri Caplain; Sylvie Rottey; Desiree Douglas; Steffan Stringer; Hildegard Sourgens
Journal:  Front Pharmacol       Date:  2019-11-29       Impact factor: 5.810

6.  Promoting Safe Early Clinical Research of Novel Drug Candidates: A European Union Regulatory Perspective.

Authors:  Stefano Ponzano; Kevin Blake; Milton Bonelli; Harald Enzmann
Journal:  Clin Pharmacol Ther       Date:  2017-11-06       Impact factor: 6.875
  6 in total

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