Woodcock, M.D., Janet: 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

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

4

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

5

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

6

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

7

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

8

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

9

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

10

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

11

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

12

FDA pharmaceutical quality oversight

Yu, Lawrence X., Woodcock, Janet

Journal:

International Journal of Pharmaceutics

Year:

2015

Language:

english

File:

PDF, 463 KB

english, 2015

13

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

14

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

15

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

16

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

17

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

18

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

19

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

20

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

21

A regulatory perspective on in vitro diagnostics

Gottlieb, Scott, Woodcock, Janet

Journal:

Nature Biotechnology

Year:

2006

Language:

english

File:

PDF, 678 KB

english, 2006

22

Pathogenetic implications of hyaluronan-induced modification of vascular smooth muscle cell fibrinolysis in diabetes

Marutsuka, Kousuke, Woodcock-Mitchell, Janet, Sakamoto, Tomohiro, Sobel, Burton E., Fujii, Satoshi

Journal:

Coronary Artery Disease

Year:

1998

File:

PDF, 606 KB

1998

23

A Benefit Risk Analysis Approach To Capture Regulatory Decision-Making: Non-Small Cell Lung Cancer

Raju, G. K., Gurumurthi, Karthik, Domike, Reuben, Kazandjian, Dickran, Blumenthal, Gideon, Pazdur, Richard, Woodcock, Janet

Journal:

Clinical Pharmacology & Therapeutics

Year:

2016

Language:

english

File:

PDF, 1.59 MB

english, 2016

24

Improving Adverse Event Reporting for Compounded Drugs

Dohm, Julie, Kim, Jenny, Woodcock, Janet

Journal:

JAMA Internal Medicine

Year:

2019

Language:

english

File:

PDF, 49 KB

english, 2019

25

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

26

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

27

Integrating Randomized Comparative Effectiveness Research with Patient Care

Drazen, Jeffrey M., Harrington, David P., McMurray, John J.V., Ware, James H., Woodcock, Janet, Fiore, Louis D., Lavori, Philip W.

Journal:

New England Journal of Medicine

Year:

2016

Language:

english

File:

PDF, 190 KB

english, 2016

28

Informed Consent

Drazen, Jeffrey M., Harrington, David P., McMurray, John J.V., Ware, James H., Woodcock, Janet, Grady, Christine, Cummings, Steven R., Rowbotham, Michael C., McConnell, Michael V., Ashley, Euan A., Ka

Journal:

New England Journal of Medicine

Year:

2017

Language:

english

File:

PDF, 328 KB

english, 2017

29

Composition of benthic macroinvertebrate assemblages in managed and preserved Adirondack headwater catchments (New York, USA)

Mihuc, Janet R., Mihuc, Timothy B., Woodcock, T., Romanowicz, E.A., Jackson, T., Myers, L., Spring, K., Tran, C., Bulova, J., Evans, E., Welch, D.

Journal:

SIL Proceedings, 1922-2010

Year:

2006

Language:

english

File:

PDF, 1.17 MB

english, 2006

30

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

31

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

32

Preventing Prescription Opioid Abuse—Reply

Jones, Christopher M., Lurie, Peter, Woodcock, Janet

Journal:

JAMA The Journal of the American Medical Association

Year:

2015

Language:

english

File:

PDF, 73 KB

english, 2015

33

Bronchoalveolar Lavage Lipids during Development of Bleomycin-induced Fibrosis in Rats: Relationship to Altered Epithelial Cell Morphology

Low, Robert B., Adler, Kenneth B., Woodcock-Mitchell, Janet, Giancola, Michael S., Vacek, Pamela M.

Journal:

American Review of Respiratory Disease

Year:

1988

Language:

english

File:

PDF, 550 KB

english, 1988

34

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

35

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

36

Developing the Nation's Biosimilars Program

Kozlowski, Steven, Woodcock, Janet, Midthun, Karen, Behrman Sherman, Rachel

Journal:

Boston Medical and Surgical Journal

Year:

2011

Language:

english

File:

PDF, 701 KB

english, 2011

37

Accelerating Identification and Regulatory Approval of Investigational Cancer Drugs

Esserman, Laura J., Woodcock, Janet

Journal:

JAMA The Journal of the American Medical Association

Year:

2011

Language:

english

File:

PDF, 136 KB

english, 2011

38

New FDA Regulation to Improve Safety Reporting in Clinical Trials

Behrman Sherman, Rachel, Woodcock, Janet, Norden, Janet, Grandinetti, Cheryl, Temple, Robert J.

Journal:

Boston Medical and Surgical Journal

Year:

2011

Language:

english

File:

PDF, 354 KB

english, 2011

39

Data Monitoring Committees — Expect the Unexpected

Drazen, Jeffrey M., Harrington, David P., McMurray, John J.V., Ware, James H., Woodcock, Janet, DeMets, David L., Ellenberg, Susan S.

Journal:

New England Journal of Medicine

Year:

2016

Language:

english

File:

PDF, 181 KB

english, 2016

40

Empowering microarrays in the regulatory setting

Casciano, Daniel A., Woodcock, Janet

Journal:

Nature Biotechnology

Year:

2006

Language:

english

File:

PDF, 56 KB

english, 2006

41

FDA introductory comments: clinical studies design and evaluation issues

Woodcock, Janet

Journal:

Clinical Trials

Year:

2005

Language:

english

File:

PDF, 657 KB

english, 2005

42

Drug-Development Challenges for Small Biopharmaceutical Companies

Drazen, Jeffrey M., Harrington, David P., McMurray, John J.V., Ware, James H., Woodcock, Janet, Moscicki, Richard A., Tandon, P.K.

Journal:

New England Journal of Medicine

Year:

2017

Language:

english

File:

PDF, 484 KB

english, 2017

43

Medication development in opioid addiction: Meaningful clinical end points

Volkow, Nora D., Woodcock, Janet, Compton, Wilson M., Throckmorton, Douglas C., Skolnick, Phil, Hertz, Sharon, Wargo, Eric M.

Journal:

Science Translational Medicine

Year:

2018

Language:

english

File:

PDF, 139 KB

english, 2018

44

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

45

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

46

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

47

Qualifying biomarkers for use in drug development: a US Food and Drug Administration overview

Woodcock, Janet, Buckman, ShaAvhree, Goodsaid, Federico, Walton, Marc K, Zineh, Issam

Journal:

Expert Opinion on Medical Diagnostics

Year:

2011

Language:

english

File:

PDF, 294 KB

english, 2011

48

Interpreting Geographic Variations in Results of Randomized, Controlled Trials

Drazen, Jeffrey M., Harrington, David P., McMurray, John J.V., Ware, James H., Woodcock, Janet, Yusuf, Salim, Wittes, Janet

Journal:

New England Journal of Medicine

Year:

2016

Language:

english

File:

PDF, 132 KB

english, 2016

49

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

50

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

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