Pharmacogenomic-guided drug development: regulatory perspective

The Pharmacogenomics Journal ◽

10.1038/sj.tpj.6500046 ◽

2002 ◽

Vol 2 (1) ◽

pp. 20-24 ◽

Author(s):

L J Lesko ◽

J Woodcock

Keyword(s):

Drug Development ◽

Regulatory Perspective

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Value of Data Sharing to Advance Drug Development: A Regulatory Perspective

Therapeutic Innovation & Regulatory Science ◽

10.1007/s43441-021-00275-y ◽

2021 ◽

Author(s):

Aliza Thompson ◽

Ameeta Parekh

Keyword(s):

Drug Development ◽

Data Sharing ◽

Regulatory Perspective

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African Americans, Kidney Disease, and Drug Development: A Regulatory Perspective

American Journal of Kidney Diseases ◽

10.1053/j.ajkd.2018.06.023 ◽

2018 ◽

Vol 72 (5) ◽

pp. S33-S36 ◽

Author(s):

Carolina Panico ◽

Aliza Thompson

Keyword(s):

African Americans ◽

Kidney Disease ◽

Drug Development ◽

Regulatory Perspective

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Regulatory perspective of biomarker bioanalysis during drug development

Bioanalysis ◽

10.4155/bio-2019-0029 ◽

2019 ◽

Vol 11 (7) ◽

pp. 607-610 ◽

Author(s):

Chongwoo Yu ◽

E Dennis Bashaw

Keyword(s):

Drug Development ◽

Regulatory Perspective

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Integration and use of biomarkers in drug development, regulation and clinical practice: a US regulatory perspective

Biomarkers in Medicine ◽

10.2217/17520363.2.3.305 ◽

2008 ◽

Vol 2 (3) ◽

pp. 305-311 ◽

Author(s):

Shashi Amur ◽

Felix W Frueh ◽

Lawrence J Lesko ◽

Shiew-Mei Huang

Keyword(s):

Clinical Practice ◽

Drug Development ◽

Regulatory Perspective ◽

Development Regulation

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Model-informed drug development approach supporting approval of the 4-week (Q4W) dosing schedule for nivolumab (Opdivo) across multiple indications: a regulatory perspective

Annals of Oncology ◽

10.1093/annonc/mdz037 ◽

2019 ◽

Vol 30 (4) ◽

pp. 644-651 ◽

Author(s):

Y. Bi ◽

J. Liu ◽

B. Furmanski ◽

H. Zhao ◽

J. Yu ◽

...

Keyword(s):

Drug Development ◽

Dosing Schedule ◽

Regulatory Perspective ◽

Development Approach

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Albuminuria as a surrogate marker for drug development: A European Regulatory perspective

Kidney International ◽

10.1111/j.1523-1755.2004.09232.x ◽

2004 ◽

Vol 66 ◽

pp. S126-S127 ◽

Author(s):

Gonzalo Calvo ◽

Fernando De Andres-Trelles

Keyword(s):

Drug Development ◽

Surrogate Marker ◽

Regulatory Perspective ◽

European Regulatory

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Radiopharmaceuticals for Drug Development: United States Regulatory Perspective

Current Radiopharmaceuticals ◽

10.2174/1874471010801010002 ◽

2008 ◽

Vol 1 (1) ◽

pp. 2-6 ◽

Author(s):

Henry VanBrocklin

Keyword(s):

United States ◽

Drug Development ◽

Regulatory Perspective

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Nanotechnology: Regulatory Perspective for Drug Development in Cancer Therapeutics

Nanotechnology for Cancer Therapy ◽

10.1201/9781420006636-8 ◽

2006 ◽

pp. 139-156

Author(s):

N. Sadrieh ◽

T. J. Miller

Keyword(s):

Drug Development ◽

Cancer Therapeutics ◽

Regulatory Perspective

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Drug Development in Oncology: A Regulatory Perspective

American Journal of Therapeutics ◽

10.1097/mjt.0b013e3181d1d833 ◽

2011 ◽

Vol 18 (4) ◽

pp. 323-331

Author(s):

Stella Augustus

Keyword(s):

Drug Development ◽

Regulatory Perspective

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Drug Development for Asthma and COPD: A Regulatory Perspective

Respiratory Care ◽

10.4187/respcare.06009 ◽

2018 ◽

Vol 63 (6) ◽

pp. 797-817

Author(s):

Marianne Mann ◽

Robert J Meyer

Keyword(s):

Drug Development ◽

Regulatory Perspective

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