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1

Regulatory and Scientific Issues Regarding Use of Foreign Data in Support of New Drug Applications in the United States: An FDA Perspective

Khin, N A, Yang, P, Hung, H M J, Maung-U, K, Chen, Y-F, Meeker-O’Connell, A, Okwesili, P, Yasuda, S U, Ball, L K, Huang, S-M, O’Neill, R T, Temple, R

Journal:

Clinical Pharmacology & Therapeutics

Year:

2013

Language:

english

File:

PDF, 1.44 MB

english, 2013

2

Methyl Parathion: A Review of Health Effects

Garcia, Stephanie, Abu-Qare, Aqel, Meeker-O'Connell, Winifred, Borton, Anita, Abou-Donia, Mohamed

Journal:

Journal of Toxicology and Environmental Health Part B

Year:

2003

Language:

english

File:

PDF, 216 KB

english, 2003

3

TransCelerate’s Clinical Quality Management System

Meeker-O’Connell, Ann, Sam, Leslie M., Bergamo, Nanci, Little, Janis A.

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2016

Language:

english

File:

PDF, 1.63 MB

english, 2016

4

Genetic diversity in the Mycobacterium tuberculosis complex based on variable numbers of tandem DNA repeats

Frothingham, R., Meeker-O'Connell, W. A

Journal:

Microbiology (Society for General Microbiology)

Year:

1998

Language:

english

File:

PDF, 1.17 MB

english, 1998

5

Quality by Design in Clinical Trials: A Collaborative Pilot With FDA

Sprenger, K., Nickerson, D., Meeker-O'Connell, A., Morrison, B. W.

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2013

Language:

english

File:

PDF, 317 KB

english, 2013

6

Central site monitoring: Results from a test of accuracy in identifying trials and sites failing Food and Drug Administration inspection

Lindblad, A. S., Manukyan, Z., Purohit-Sheth, T., Gensler, G., Okwesili, P., Meeker-O'Connell, A., Ball, L., Marler, J. R.

Journal:

Clinical Trials

Year:

2014

Language:

english

File:

PDF, 3.39 MB

english, 2014

7

Enhancing Quality and Efficiency in Clinical Development Through a Clinical QMS Conceptual Framework: Concept Paper Vision and Outline

Meeker-O'Connell, A., Borda, M. M., Little, J. A., Sam, L. M.

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2015

Language:

english

File:

PDF, 476 KB

english, 2015

8

Improving public health by improving clinical trial guidelines and their application

Landray, Martin J., Bax, Jeroen J., Alliot, Laurence, Buyse, Marc, Cohen, Adam, Collins, Rory, Hindricks, Gerhard, James, Stefan K., Lane, Sile, Maggioni, Aldo P., Meeker-O'Connell, Ann, Olsson, Gunna

Journal:

European Heart Journal

Year:

2017

Language:

english

File:

PDF, 259 KB

english, 2017

9

Clinical trial quality: From supervision to collaboration and beyond

Meeker-O’Connell, Ann, Glessner, Coleen

Journal:

Clinical Trials

Year:

2018

Language:

english

File:

PDF, 687 KB

english, 2018

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