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Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both
Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both
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Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both

Woodcock, Janet ; LaVange, Lisa M McMurray, John J.V ; Drazen, Jeffrey M ; Woodcock, Janet ; Harrington, David P ; Ware, James H ; Drazen, Jeffrey M. ; McMurray, John J.V. ; Ware, James H. ; Harrington, David P.

The New England journal of medicine, 2017-07, Vol.377 (1), p.62-70 [Periódico revisado por pares]

United States: Massachusetts Medical Society

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2
Real-World Evidence and Real-World Data for Evaluating Drug Safety and Effectiveness
Real-World Evidence and Real-World Data for Evaluating Drug Safety and Effectiveness
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Real-World Evidence and Real-World Data for Evaluating Drug Safety and Effectiveness

Corrigan-Curay, Jacqueline ; Sacks, Leonard ; Woodcock, Janet

JAMA : the journal of the American Medical Association, 2018-09, Vol.320 (9), p.867-868 [Periódico revisado por pares]

United States: American Medical Association

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3
The FDA critical path initiative and its influence on new drug development
The FDA critical path initiative and its influence on new drug development
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The FDA critical path initiative and its influence on new drug development

Woodcock, Janet ; Woosley, Raymond

Annual review of medicine, 2008-01, Vol.59 (1), p.1-12 [Periódico revisado por pares]

United States: Annual Reviews, Inc

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4
Understanding Pharmaceutical Quality by Design
Understanding Pharmaceutical Quality by Design
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Understanding Pharmaceutical Quality by Design

Yu, Lawrence X. ; Amidon, Gregory ; Khan, Mansoor A. ; Hoag, Stephen W. ; Polli, James ; Raju, G. K. ; Woodcock, Janet

The AAPS journal, 2014-07, Vol.16 (4), p.771-783 [Periódico revisado por pares]

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5
Immune-mediated pathology in Duchenne muscular dystrophy
Immune-mediated pathology in Duchenne muscular dystrophy
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Immune-mediated pathology in Duchenne muscular dystrophy

Rosenberg, Amy S ; Puig, Montserrat ; Nagaraju, Kanneboyina ; Hoffman, Eric P ; Villalta, S Armando ; Rao, V Ashutosh ; Wakefield, Lalage M ; Woodcock, Janet

Science translational medicine, 2015-08, Vol.7 (299), p.299rv4-299rv4 [Periódico revisado por pares]

United States

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6
Modernizing Pharmaceutical Manufacturing: from Batch to Continuous Production
Modernizing Pharmaceutical Manufacturing: from Batch to Continuous Production
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Modernizing Pharmaceutical Manufacturing: from Batch to Continuous Production

Lee, Sau L. ; O’Connor, Thomas F. ; Yang, Xiaochuan ; Cruz, Celia N. ; Chatterjee, Sharmista ; Madurawe, Rapti D. ; Moore, Christine M. V. ; Yu, Lawrence X. ; Woodcock, Janet

Journal of pharmaceutical innovation, 2015-09, Vol.10 (3), p.191-199 [Periódico revisado por pares]

New York: Springer US

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7
Regulatory Action on Rosiglitazone by the U.S. Food and Drug Administration
Regulatory Action on Rosiglitazone by the U.S. Food and Drug Administration
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Regulatory Action on Rosiglitazone by the U.S. Food and Drug Administration

Woodcock, Janet ; Sharfstein, Joshua M ; Hamburg, Margaret

The New England journal of medicine, 2010-10, Vol.363 (16), p.1489-1491 [Periódico revisado por pares]

United States: Massachusetts Medical Society

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8
Expediting Drug Development — The FDA's New “Breakthrough Therapy” Designation
Expediting Drug Development — The FDA's New “Breakthrough Therapy” Designation
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Expediting Drug Development — The FDA's New “Breakthrough Therapy” Designation

Sherman, Rachel E. ; Li, Jun ; Shapley, Stephanie ; Robb, Melissa ; Woodcock, Janet

The New England journal of medicine, 2013-11, Vol.369 (20), p.1877-1880 [Periódico revisado por pares]

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9
Biosimilars: The US Regulatory Framework
Biosimilars: The US Regulatory Framework
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Biosimilars: The US Regulatory Framework

Christl, Leah A ; Woodcock, Janet ; Kozlowski, Steven

Annual review of medicine, 2017-01, Vol.68 (1), p.243-254 [Periódico revisado por pares]

United States: Annual Reviews

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10
Advancing the Science for Active Surveillance: Rationale and Design for the Observational Medical Outcomes Partnership
Advancing the Science for Active Surveillance: Rationale and Design for the Observational Medical Outcomes Partnership
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Advancing the Science for Active Surveillance: Rationale and Design for the Observational Medical Outcomes Partnership

STANG, Paul E ; RYAN, Patrick B ; RACOOSIN, Judith A ; OVERHAGE, J. Marc ; HARTZEMA, Abraham G ; REICH, Christian ; WELEBOB, Emily ; SCARNECCHIA, Thomas ; WOODCOCK, Janet

Annals of internal medicine, 2010-11, Vol.153 (9), p.600-606 [Periódico revisado por pares]

Philadelphia, PA: American College of Physicians

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