Literature DB >> 27074059

Seamless Oncology-Drug Development.

Tatiana M Prowell1, Marc R Theoret1, Richard Pazdur1.   

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Year:  2016        PMID: 27074059     DOI: 10.1056/NEJMp1603747

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


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  37 in total

1.  Flexibility and innovation in the FDA's novel regulatory approval strategies for hematologic drugs.

Authors:  Ann T Farrell; Kirsten B Goldberg; Richard Pazdur
Journal:  Blood       Date:  2017-08-03       Impact factor: 22.113

2.  EFFICACY-TO-EFFECTIVENESS CLINICAL TRIALS.

Authors:  Harry P Selker; Sheeona Gorman; Kenneth I Kaitin
Journal:  Trans Am Clin Climatol Assoc       Date:  2018

Review 3.  Evolution of early phase clinical trials in oncology.

Authors:  Nam Q Bui; Shivaani Kummar
Journal:  J Mol Med (Berl)       Date:  2017-11-24       Impact factor: 4.599

4.  Paediatrics: Metronomics - fulfilling unmet needs beyond level A evidence.

Authors:  Nicolas André; Shripad Banavali; Eddy Pasquier
Journal:  Nat Rev Clin Oncol       Date:  2016-06-28       Impact factor: 66.675

Review 5.  Precision medicine in pediatric oncology: Lessons learned and next steps.

Authors:  Rajen J Mody; John R Prensner; Jessica Everett; D Williams Parsons; Arul M Chinnaiyan
Journal:  Pediatr Blood Cancer       Date:  2016-10-17       Impact factor: 3.167

6.  Advancing Drug Development in Gynecologic Malignancies.

Authors:  Julia A Beaver; Robert L Coleman; Rebecca C Arend; Deborah K Armstrong; Sanjeeve Bala; Gordon B Mills; Anil K Sood; Thomas J Herzog
Journal:  Clin Cancer Res       Date:  2019-05-24       Impact factor: 12.531

7.  An Analysis of Recent FDA Oncology Scientific Publications.

Authors:  Julie A Schneider; Andrew C Miklos; James Onken; Yutao Gong; Anna Maria Calcagno; Gideon M Blumenthal; Richard Aragon; Richard Pazdur
Journal:  Oncologist       Date:  2019-11-26

8.  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

Review 9.  The evolving paradigm of cancer trials.

Authors:  Shivaani Kummar
Journal:  Nat Rev Drug Discov       Date:  2017-12-22       Impact factor: 84.694

10.  From Famine to Feast: Developing Early-Phase Combination Immunotherapy Trials Wisely.

Authors:  Daphne Day; Arta M Monjazeb; Elad Sharon; S Percy Ivy; Eric H Rubin; Gary L Rosner; Marcus O Butler
Journal:  Clin Cancer Res       Date:  2017-09-01       Impact factor: 12.531

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