Janet L. Woodcock: search on Z-Library

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1

Understanding Pharmaceutical Quality by Design

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

Journal:

The AAPS Journal

Year:

2014

Language:

english

File:

PDF, 523 KB

english, 2014

2

The FDA and the Next Wave of Drug Abuse — Proactive Pharmacovigilance

Throckmorton, Douglas C., Gottlieb, Scott, Woodcock, Janet

Journal:

New England Journal of Medicine

Year:

2018

Language:

english

File:

PDF, 314 KB

english, 2018

3

Scientific considerations in the review and approval of generic enoxaparin in the United States

Lee, Sau, Raw, Andre, Yu, Lawrence, Lionberger, Robert, Ya, Naiqi, Verthelyi, Daniela, Rosenberg, Amy, Kozlowski, Steve, Webber, Keith, Woodcock, Janet

Journal:

Nature Biotechnology

Year:

2013

Language:

english

File:

PDF, 639 KB

english, 2013

4

Challenges in the Design and Interpretation of Noninferiority Trials

Drazen, Jeffrey M., Harrington, David P., McMurray, John J.V., Ware, James H., Woodcock, Janet, Mauri, Laura, D’Agostino, Ralph B.

Journal:

New England Journal of Medicine

Year:

2017

Language:

english

File:

PDF, 606 KB

english, 2017

5

The first crop plant genetically engineered to release an insect pheromone for defence

Bruce, Toby J.A., Aradottir, Gudbjorg I., Smart, Lesley E., Martin, Janet L., Caulfield, John C., Doherty, Angela, Sparks, Caroline A., Woodcock, Christine M., Birkett, Michael A., Napier, Johnathan A

Journal:

Scientific Reports

Year:

2015

Language:

english

File:

PDF, 720 KB

english, 2015

6

A regulatory perspective on in vitro diagnostics

Gottlieb, Scott, Woodcock, Janet

Journal:

Nature Biotechnology

Year:

2006

Language:

english

File:

PDF, 678 KB

english, 2006

7

The FDA Critical Path Initiative and Its Influence on New Drug Development*

Woodcock, Janet, Woosley, Raymond

Journal:

Annual Review of Medicine

Year:

2008

Language:

english

File:

PDF, 232 KB

english, 2008

8

Role of Postmarketing Surveillance in Contemporary Medicine *

Woodcock, Janet, Behrman, Rachel E., Dal Pan, Gerald J.

Journal:

Annual Review of Medicine

Year:

2011

Language:

english

File:

PDF, 1.02 MB

english, 2011

9

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:

Journal of Pharmaceutical Innovation

Year:

2015

Language:

english

File:

PDF, 571 KB

english, 2015

10

Reviews

Collins, Nigel, Dolan, Ann, Fairbrother, Bob, Dixon, Angela, Woodcock, John, Turner, Sheila, Mulley, Carolyn A., Knight, C. D., Necklen, David, Bennett, Janet, Hitchen, E. T., Dick, Jan, Flaherty, A.

Journal:

Journal of Biological Education

Year:

1991

Language:

english

File:

PDF, 1.27 MB

english, 1991

11

Pragmatic Trials

Drazen, Jeffrey M., Harrington, David P., McMurray, John J.V., Ware, James H., Woodcock, Janet, Ford, Ian, Norrie, John

Journal:

New England Journal of Medicine

Year:

2016

Language:

english

File:

PDF, 136 KB

english, 2016

12

The Primary Outcome Is Positive — Is That Good Enough?

Drazen, Jeffrey M., Harrington, David P., McMurray, John J.V., Ware, James H., Woodcock, Janet, Pocock, Stuart J., Stone, Gregg W.

Journal:

New England Journal of Medicine

Year:

2016

Language:

english

File:

PDF, 694 KB

english, 2016

13

Advancing pharmaceutical quality: An overview of science and research in the U.S. FDA’s Office of Pharmaceutical Quality

Fisher, Adam C., Lee, Sau L., Harris, Daniel P., Buhse, Lucinda, Kozlowski, Steven, Yu, Lawrence, Kopcha, Michael, Woodcock, Janet

Journal:

International Journal of Pharmaceutics

Year:

2016

Language:

english

File:

PDF, 1.06 MB

english, 2016

14

Biosimilars: The US Regulatory Framework

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

Journal:

Annual Review of Medicine

Year:

2017

Language:

english

File:

PDF, 362 KB

english, 2017

15

Evidence for Health Decision Making — Beyond Randomized, Controlled Trials

Drazen, Jeffrey M., Harrington, David P., McMurray, John J.V., Ware, James H., Woodcock, Janet, Frieden, Thomas R.

Journal:

New England Journal of Medicine

Year:

2017

Language:

english

File:

PDF, 154 KB

english, 2017

16

Expediting drug development for serious illness: Trade-offs between patient access and certainty

Woodcock, Janet

Journal:

Clinical Trials

Year:

2018

Language:

english

File:

PDF, 79 KB

english, 2018

17

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

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

Journal:

Year:

2018

Language:

english

File:

PDF, 49 KB

english, 2018

18

Using A Benefit Risk Analysis Approach To Capture Regulatory Decision‐Making: Melanoma

Raju, G K, Gurumurthi, Karthik, Domike, Reuben, Theoret, Marc R., Pazdur, Richard, Woodcock, Janet

Journal:

Clinical Pharmacology & Therapeutics

Year:

2019

Language:

english

File:

PDF, 1.98 MB

english, 2019

19

Using a Benefit Risk Analysis Approach To Capture Regulatory Decision‐Making: Renal Cell Carcinoma

Raju, G K, Gurumurthi, Karthik, Domike, Reuben, Weinstock, Chana, Singh, Harpreet, Kluetz, Paul, Pazdur, Richard, Woodcock, Janet

Journal:

Clinical Pharmacology & Therapeutics

Year:

2019

Language:

english

File:

PDF, 1.45 MB

english, 2019

20

Bridging the Gap at Warp Speed â Delivering Options for Preventing and Treating Covid-19

Slaoui, Moncef, Greene, Shannon E., Woodcock, Janet

Journal:

New England Journal of Medicine

Year:

2020

File:

PDF, 360 KB

2020

21

Inhibition of calcium and glucose uptake by murine leukemia L5178Y cells treated with antiserum

Janet Woodcock-Mitchell, Tsu-Ju (Thomas) Yang

Journal:

Journal of Cellular Physiology

Year:

1980

Language:

english

File:

PDF, 594 KB

english, 1980

22

Cytomatrix synthesis in MDCK epithelial cells

John J. Mitchell, Robert B. Low, Janet L. Woodcock-Mitchell

Journal:

Journal of Cellular Physiology

Year:

1990

Language:

english

File:

PDF, 1.23 MB

english, 1990

23

Interference of sucrose with the fluorometric assay of tryptophan

Janet L. Woodcock, Edward A. Khairallah

Journal:

Analytical Biochemistry

Year:

1976

Language:

english

File:

PDF, 367 KB

english, 1976

24

Effect of antiserum on leukemia 15178y cells: [3H]thymidine incorporation does not reflect dna synthesis

Janet Woodcock-Mitchell, Tsu-Ju(Thomas) Yang

Journal:

International Journal of Biochemistry

Year:

1982

Language:

english

File:

PDF, 750 KB

english, 1982

25

Mapping land-cover modifications over large areas: A comparison of machine learning algorithms

John Rogan, Janet Franklin, Doug Stow, Jennifer Miller, Curtis Woodcock, Dar Roberts

Journal:

Remote Sensing of Environment

Year:

2008

Language:

english

File:

PDF, 842 KB

english, 2008

26

A Neural Network Method for Efficient Vegetation Mapping

Gail A. Carpenter, Sucharita Gopal, Scott Macomber, Siegfried Martens, Curtis E. Woodcock, Janet Franklin

Journal:

Remote Sensing of Environment

Year:

1999

Language:

english

File:

PDF, 1.25 MB

english, 1999

27

Risk Management: Issues for Outcomes Research

Journal:

Value in Health

Year:

2003

Language:

english

File:

PDF, 58 KB

english, 2003

28

The US Food and Drug Administration's Sentinel Initiative: Expanding the horizons of medical product safety

Melissa A. Robb, Judith A. Racoosin, Rachel E. Sherman, Thomas P. Gross, Robert Ball, Marsha E. Reichman, Karen Midthun, Janet Woodcock

Journal:

Pharmacoepidemiology and Drug Safety

Year:

2012

Language:

english

File:

PDF, 67 KB

english, 2012

29

Remote sensing for land management and planning

Curtis E. Woodcock, Alan H. Strahler, Janet Franklin

Journal:

Environmental Management

Year:

1983

Language:

english

File:

PDF, 3.19 MB

english, 1983

30

Keratin Classes: Molecular Markers for Different Types of Epithelial Differentiation.

Tung-Tien Sun,, Eichner, Riva, Nelson, William G., Tseng, Scheffer C. G., Weiss, Robert A., Jarvinen, Mikko, Woodcock-Mitchell, Janet

Journal:

The Journal of Investigative Dermatology

Year:

1983

File:

PDF, 4.03 MB

1983

31

Research at the interface of industry, academia and regulatory science

Mattes, William B, Walker, Elizabeth Gribble, Abadie, Eric, Sistare, Frank D, Vonderscher, Jacky, Woodcock, Janet, Woosley, Raymond L

Journal:

Nature Biotechnology

Year:

2010

Language:

english

File:

PDF, 91 KB

english, 2010

32

Empowering microarrays in the regulatory setting

Casciano, Daniel A., Woodcock, Janet

Journal:

Nature Biotechnology

Year:

2006

Language:

english

File:

PDF, 56 KB

english, 2006

33

Medical applications of microarray technologies: a regulatory science perspective

Petricoin, Emanuel F., Hackett, Joseph L., Lesko, Lawrence J., Puri, Raj K., Gutman, Steven I., Chumakov, Konstantin, Woodcock, Janet, Feigal, David W., Zoon, Kathryn C., Sistare, Frank D.

Journal:

Nature Genetics

Year:

2002

Language:

english

File:

PDF, 104 KB

english, 2002

34

Opinion: Translation of pharmacogenomics and pharmacogenetics: a regulatory perspective

Lesko, Lawrence J., Woodcock, Janet

Journal:

Nature Reviews Drug Discovery

Year:

2004

Language:

english

File:

PDF, 147 KB

english, 2004

35

The FDA's assessment of follow-on protein products: a historical perspective

Woodcock, Janet, Griffin, Joseph, Behrman, Rachel, Cherney, Barry, Crescenzi, Terrie, Fraser, Blair, Hixon, Dena, Joneckis, Christopher, Kozlowski, Steven, Rosenberg, Amy

Journal:

Nature Reviews Drug Discovery

Year:

2007

Language:

english

File:

PDF, 200 KB

english, 2007

36

Stimulating the development of mechanism-based, individualized pain therapies

Woodcock, Janet, Witter, James, Dionne, Raymond A.

Journal:

Nature Reviews Drug Discovery

Year:

2007

Language:

english

File:

PDF, 430 KB

english, 2007

37

Transporters in drug development: advancing on the Critical Path

Huang, Shiew-Mei, Woodcock, Janet

Journal:

Nature Reviews Drug Discovery

Year:

2010

Language:

english

File:

PDF, 161 KB

english, 2010

38

Long-term blockade of nitric oxide synthesis in rats modulates coronary capillary network remodeling

Daisuke Goto, Satoshi Fujii, A.K.M. Tarikuz Zaman, Ichiro Sakuma, Ming Gao, Tomiyasu Koyama, John Mitchell, Janet Woodcock-Mitchell, Burton E. Sobel, Akira Kitabatake

Journal:

Year:

1999

Language:

english

File:

PDF, 227 KB

english, 1999

39

Role of cyclic AMP in antiserum-induced growth inhibition of murine leukemia L5178Y cells

Janet Woodcock-Mitchell, Tsu-Ju (Thomas) Yang

Journal:

Leukemia Research

Year:

1985

Language:

english

File:

PDF, 520 KB

english, 1985

40

Janet Woodcock discusses the FDA and the drug development process

Christopher Watson, Janet Woodcock

Journal:

Drug Discovery Today

Year:

2004

Language:

english

File:

PDF, 248 KB

english, 2004

41

α-Smooth muscle actin is transiently expressed in embryonic rat cardiac and skeletal muscles

Janet Woodcock-Mitchell, John J. Mitchell, Robert B. Low, Madeleine Kieny, Philippe Sengel, Laura Rubbia, Omar Skalli, Brian Jackson, Giulio Gabbiani

Journal:

Differentiation

Year:

1988

Language:

english

File:

PDF, 1.81 MB

english, 1988

42

Alpha smooth muscle actin expression in developing and adult human lung

Kevin O. Leslie, John J. Mitchell, Janet L. Woodcock-Mitchell, Robert B. Low

Journal:

Differentiation

Year:

1990

Language:

english

File:

PDF, 905 KB

english, 1990

43

A NEW BUTADIENE DERIVATIVE, T-686, INHIBITS PLASMINOGEN ACTIVATOR INHIBITOR TYPE-1 PRODUCTION IN VITRO BY CULTURED HUMAN VASCULAR ENDOTHELIAL CELLS AND DEVELOPMENT OF ATHEROSCLEROTIC LESIONS IN VIVO IN RABBITS

Boris Vinogradsky, Stephen P Bell, Janet Woodcock-Mitchell, Akio Ohtani, Satoshi Fujii

Journal:

Thrombosis Research

Year:

1997

Language:

english

File:

PDF, 1.44 MB

english, 1997

44

FDA public health advisory: Potential for injury from medical gas misconnections of cryogenic vessels

David W. Feigal Jr, Janet Woodcock

Journal:

International Journal of Trauma Nursing

Year:

2001

Language:

english

File:

PDF, 45 KB

english, 2001

45

Hypotension and bedside leukocyte reduction filters

Kathryn C. Zoon, Elizabeth D. Jacobson, Janet Woodcock

Journal:

International Journal of Trauma Nursing

Year:

1999

Language:

english

File:

PDF, 479 KB

english, 1999

46

Correlation of specific keratins with different types of epithelial differentiation: Monoclonal antibody studies

Scheffer C.G. Tseng, Mikko J. Jarvinen, William G. Nelson, Jing-Wei Huang, Janet Woodcock-Mitchell, Tung-Tien Sun

Journal:

Year:

1982

Language:

english

File:

PDF, 12.88 MB

english, 1982

47

Principles of Clinical Pharmacology || Physiological and Laboratory Markers of Drug Effect

Woodcock, Janet

Year:

2012

Language:

english

File:

PDF, 491 KB

english, 2012

48

Human and murine natural killer cell activity may require lipoxygenation of arachidonic acid

Seaman, William E., Woodcock, Janet

Journal:

Journal of Allergy and Clinical Immunology

Year:

1984

Language:

english

File:

PDF, 538 KB

english, 1984

49

FDA's Critical Path Initiative

Journal:

Drug Discovery Today: Technologies

Year:

2007

Language:

english

File:

PDF, 68 KB

english, 2007

50

FDA's Critical Path Initiative

Journal:

Drug Discovery Today: Technologies

Year:

2007

Language:

english

File:

PDF, 69 KB

english, 2007

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