| nr |
titel |
auteur |
tijdschrift |
jaar |
jaarg. |
afl. |
pagina('s) |
type |
| 1 |
Biogeneric Regulatory Policies in China and India: A Comparison Study
|
Guise, Jeffery W.
|
|
|
44 |
1 |
p. 55-67
|
artikel
|
| 2 |
Circadian Variation in QT Interval Demonstrating Assay Sensitivity in a Phase 1 Clinical Trial
|
Bourdillon, Peter J.
|
|
|
44 |
1 |
p. 1-7
|
artikel
|
| 3 |
Discussion Based on the Survey Results of Authorities’ Inquiries during NDA Review in Japan
|
Numazaki, Reiko
|
|
|
44 |
1 |
p. 69-79
|
artikel
|
| 4 |
Issues with Medical Device Spontaneous Reporting and Improvements through MedSun
|
Ostuni, Melissa
|
|
|
44 |
1 |
p. 87-95
|
artikel
|
| 5 |
Leveraging Technology to Increase Efficiency and Quality for Regulatory Submissions
|
Sichort, Patricia
|
|
|
44 |
1 |
p. 43-48
|
artikel
|
| 6 |
Mentoring in the Pharmaceutical Industry: Developing an Effective Program for a Field-based Medical Team
|
Schreiner, Barb
|
|
|
44 |
1 |
p. 81-86
|
artikel
|
| 7 |
Rationale for Sponsor-unblinded Phase 1 Trials: Challenging the Double-blind Paradigm
|
Ganju, Jitendra
|
|
|
44 |
1 |
p. 21-27
|
artikel
|
| 8 |
Reduction of Variability of Response-Adaptive Designs for Continuous Treatment Responses in Phase 3 Clinical Trials
|
Biswas, Atonu
|
|
|
44 |
1 |
p. 9-19
|
artikel
|
| 9 |
Review of Pediatric Drug Development: Concepts and Applications
|
Allio, Theresa
|
|
|
44 |
1 |
p. 97-99
|
artikel
|
| 10 |
Standard Operating Procedures (SOPs): How Companies Can Determine Which Documents They Must Put in Place
|
Gough, Janet
|
|
|
44 |
1 |
p. 49-54
|
artikel
|
| 11 |
Statistical Computing Environments and the Practice of Statistics in the Biopharmaceutical Industry
|
Hopkins, Alan
|
|
|
44 |
1 |
p. 29-42
|
artikel
|
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