| nr |
titel |
auteur |
tijdschrift |
jaar |
jaarg. |
afl. |
pagina('s) |
type |
| 1 |
A Comparison of the Drug Review Process at Five International Regulatory Agencies
|
Hirako, Mayu
|
|
|
41 |
3 |
p. 291-308
|
artikel
|
| 2 |
2007 Annual Meeting Student Poster Abstracts
|
|
|
|
41 |
3 |
p. 423-428
|
artikel
|
| 3 |
A Standard Computable Clinical Trial Protocol: The Role of the BRIDG Model
|
Willoughby, Cara
|
|
|
41 |
3 |
p. 383-392
|
artikel
|
| 4 |
Controlled Terminology for Clinical Research: A Collaboration between CDISC and NCI Enterprise Vocabulary Services
|
Haber, Margaret W.
|
|
|
41 |
3 |
p. 405-412
|
artikel
|
| 5 |
Data Standards: At the Intersection of Sites, Clinical Research Networks, and Standards Development Initiatives
|
McCourt, Brian
|
|
|
41 |
3 |
p. 393-404
|
artikel
|
| 6 |
Exploratory IND Studies: A Review of Food and Drug Administration Guidance and Similar Provision in Europe
|
Attarchi, Faraneh
|
|
|
41 |
3 |
p. 309-314
|
artikel
|
| 7 |
Introduction
|
Croswell, Roger W.
|
|
|
41 |
3 |
p. 343
|
artikel
|
| 8 |
Manual of Drug Safety and Pharmacovigilance
|
Stang, Paul
|
|
|
41 |
3 |
p. 429-430
|
artikel
|
| 9 |
Perspective on Quality Risk Management of Pharmaceutical Quality
|
Claycamp, H. Gregg
|
|
|
41 |
3 |
p. 353-367
|
artikel
|
| 10 |
Potential Predictors of Placebo Response: Lessons from a Large Database
|
Entsuah, Richard
|
|
|
41 |
3 |
p. 315-330
|
artikel
|
| 11 |
Prescription Drug Advertising and Promotion: Learnings from Recent Food and Drug Administration Warning Letters
|
Benson, Eric B.
|
|
|
41 |
3 |
p. 281-289
|
artikel
|
| 12 |
Revolutionizing the Role of Quality Assurance in Clinical Trials
|
Brown, Patricia W.
|
|
|
41 |
3 |
p. 332-342
|
artikel
|
| 13 |
Special Section on Clinical Research Standards Introduction
|
Bleicher, Paul
|
|
|
41 |
3 |
p. 369-371
|
artikel
|
| 14 |
The 505(b)(2) New Drug Application
|
Prue, J. Christopher
|
|
|
41 |
3 |
p. 349-352
|
artikel
|
| 15 |
The Probability of Registrational Success
|
Maniglia, Charles A.
|
|
|
41 |
3 |
p. 345-347
|
artikel
|
| 16 |
7th Middle East Regulatory Conference (MERC)
|
Whiting, Elaine
|
|
|
41 |
3 |
p. 413-421
|
artikel
|
| 17 |
Toward a Comprehensive CDISC Submission Data Standard
|
Kubick, Wayne R.
|
|
|
41 |
3 |
p. 373-382
|
artikel
|
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