Literature DB >> 21691273

Regulatory science as a bridge between science and society.

T Tominaga1, Y Asahina, Y Uyama, T Kondo.   

Abstract

Development of innovative drugs has recently become more difficult. The case of rosiglitazone shows the extreme difficulty of making the regulatory decision that will best balance the benefits and risks of a drug. There is a high expectation that regulatory science (RS) can improve the situation. However, without user understanding of its basic characteristics, RS will not deliver what is expected.

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Year:  2011        PMID: 21691273     DOI: 10.1038/clpt.2011.89

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


  5 in total

1.  Regulatory science: Regulation is too important to leave it to the regulators.

Authors:  Hubert G Leufkens
Journal:  Br J Clin Pharmacol       Date:  2019-04-10       Impact factor: 4.335

2.  International models of investigator-initiated trials: implications for Japan.

Authors:  E L Trimble; J Ledermann; K Law; T Miyata; C K Imamura; B-H Nam; Y H Kim; Y-J Bang; M Michaels; D Ardron; S Amano; Y Ando; T Tominaga; K Kurokawa; N Takebe
Journal:  Ann Oncol       Date:  2012-07-25       Impact factor: 32.976

Review 3.  Dental regenerative therapy targeting sphingosine-1-phosphate (S1P) signaling pathway in endodontics.

Authors:  Etsuko Matsuzaki; Masahiko Minakami; Noriyoshi Matsumoto; Hisashi Anan
Journal:  Jpn Dent Sci Rev       Date:  2020-10-13

Review 4.  A perspective on the benefit-risk assessment for new and emerging pharmaceuticals in Japan.

Authors:  Tetsuya Tanimoto
Journal:  Drug Des Devel Ther       Date:  2015-03-31       Impact factor: 4.162

5.  Trends in clinical development timeframes for antiviral drugs launched in the UK, 1981-2014: a retrospective observational study.

Authors:  Derek J Ward; Edward Hammond; Luan Linden-Phillips; Andrew J Stevens
Journal:  BMJ Open       Date:  2015-11-16       Impact factor: 2.692

  5 in total

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