Literature DB >> 26931085

Regulatory Watch: Impact of breakthrough therapy designation on cancer drug development.

Michael Shea1, Linda Ostermann1, Ryan Hohman1, Samantha Roberts1, Marina Kozak1, Ryan Dull1, Jeff Allen1, Ellen Sigal1.   

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Year:  2016        PMID： 26931085     DOI： 10.1038/nrd.2016.19

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


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  6 in total

1.  Why Drugs Fail in Late Stages of Development: Case Study Analyses from the Last Decade and Recommendations.

Authors:  Dolly A Parasrampuria; Leslie Z Benet; Amarnath Sharma
Journal:  AAPS J       Date:  2018-03-13       Impact factor: 4.009

Review 2.  The future of clinical trials in urological oncology.

Authors:  Vikram M Narayan; Philipp Dahm
Journal:  Nat Rev Urol       Date:  2019-10-11       Impact factor: 14.432

3.  Oncology Drug Approvals: Evaluating Endpoints and Evidence in an Era of Breakthrough Therapies.

Authors:  Gideon M Blumenthal; Paul G Kluetz; Julie Schneider; Kirsten B Goldberg; Amy E McKee; Richard Pazdur
Journal:  Oncologist       Date:  2017-06-02

Review 4.  Drug development in Alzheimer's disease: the path to 2025.

Authors:  Jeffrey Cummings; Paul S Aisen; Bruno DuBois; Lutz Frölich; Clifford R Jack; Roy W Jones; John C Morris; Joel Raskin; Sherie A Dowsett; Philip Scheltens
Journal:  Alzheimers Res Ther       Date:  2016-09-20       Impact factor: 6.982

Review 5.  Seamless Designs: Current Practice and Considerations for Early-Phase Drug Development in Oncology.

Authors:  Brian P Hobbs; Pedro C Barata; Yada Kanjanapan; Channing J Paller; Jane Perlmutter; Gregory R Pond; Tatiana M Prowell; Eric H Rubin; Lesley K Seymour; Nolan A Wages; Timothy A Yap; David Feltquate; Elizabeth Garrett-Mayer; William Grossman; David S Hong; S Percy Ivy; Lillian L Siu; Steven A Reeves; Gary L Rosner
Journal:  J Natl Cancer Inst       Date:  2019-02-01       Impact factor: 13.506

6.  Adaptive Biomedical Innovation: Evolving Our Global System to Sustainably and Safely Bring New Medicines to Patients in Need.

Authors:  G Hirsch; M Trusheim; E Cobbs; M Bala; S Garner; D Hartman; K Isaacs; M Lumpkin; R Lim; K Oye; E Pezalla; P Saltonstall; H Selker
Journal:  Clin Pharmacol Ther       Date:  2016-10-22       Impact factor: 6.875
  6 in total

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