| nr |
titel |
auteur |
tijdschrift |
jaar |
jaarg. |
afl. |
pagina('s) |
type |
| 1 |
Aligning Estimators With Estimands in Clinical Trials: Putting the ICH E9(R1) Guidelines Into Practice
|
Mallinckrodt, C. H.
|
|
|
54 |
2 |
p. 353-364
|
artikel
|
| 2 |
Analysis of the Authorized Target Populations for Fixed Dose Combination Products Between 2000 and 2017 Reveals Discrepancies Between EMA’s and FDA’s Views on Initial Dual-Therapy
|
Bjerrum, Ole Jannik
|
|
|
54 |
2 |
p. 297-302
|
artikel
|
| 3 |
Assessing Real-World Data Quality: The Application of Patient Registry Quality Criteria to Real-World Data and Real-World Evidence
|
Gliklich, Richard E.
|
|
|
54 |
2 |
p. 303-307
|
artikel
|
| 4 |
A Study Design for Augmenting the Control Group in a Randomized Controlled Trial: A Quality Process for Interaction Among Stakeholders
|
Xu, Yunling
|
|
|
54 |
2 |
p. 269-274
|
artikel
|
| 5 |
A Time of Optimism: Targeted Immunotherapeutics as the Long-Awaited Armamentaria Against the Scourge of Human Diseases
|
Oo, Charles
|
|
|
54 |
2 |
p. 444-446
|
artikel
|
| 6 |
Barriers for Pharmaceutical Innovation With Focus in Cancer Drugs, the Case of Mexico
|
Duenas-Gonzalez, Alfonso
|
|
|
54 |
2 |
p. 342-352
|
artikel
|
| 7 |
Building a Better Approach for the Benefit of Patients: 10 Pillars to Strengthen Regulatory Review Systems Globally
|
O’Brien, Julie
|
|
|
54 |
2 |
p. 283-292
|
artikel
|
| 8 |
Choosing Estimands in Clinical Trials: Putting the ICH E9(R1) Into Practice
|
Ratitch, Bohdana
|
|
|
54 |
2 |
p. 324-341
|
artikel
|
| 9 |
Defining Efficacy Estimands in Clinical Trials: Examples Illustrating ICH E9(R1) Guidelines
|
Ratitch, Bohdana
|
|
|
54 |
2 |
p. 370-384
|
artikel
|
| 10 |
Disease Modification in Alzheimer’s Disease: Current Thinking
|
Liu-Seifert, Hong
|
|
|
54 |
2 |
p. 396-403
|
artikel
|
| 11 |
Estimating the Impact of Food and Drug Administration’s Unapproved Drug Initiative on Drug Prices and Sales
|
Sharma, Dolly
|
|
|
54 |
2 |
p. 424-430
|
artikel
|
| 12 |
Evaluating Literature for Oncology DataGaps to Improve the Quality of StandardResponse Letters: A Retrospective Review
|
Monestime, Shanada
|
|
|
54 |
2 |
p. 385-389
|
artikel
|
| 13 |
Evaluating REMS Burden: A Comparative Time Analysis of 3 Channels for REMS Stakeholders to Perform Mandatory REMS Tasks
|
Chapman, Jennifer
|
|
|
54 |
2 |
p. 318-323
|
artikel
|
| 14 |
Evaluating the Understandability and Actionability of Web-Based Education Materials for Patients Taking Non–vitamin K Oral Anticoagulants
|
Yiu, Angela
|
|
|
54 |
2 |
p. 476-483
|
artikel
|
| 15 |
Evaluation of Legal Legislation Compliance and Readability of Clinical Trial Informed Consent Forms
|
Gungor, Buket
|
|
|
54 |
2 |
p. 468-475
|
artikel
|
| 16 |
Exact Confidence Limits on Some New Measures of Concordance and Discordance in Binary Outcomes
|
Lui, Kung-Jong
|
|
|
54 |
2 |
p. 437-443
|
artikel
|
| 17 |
Exact Unconditional Tests for Dichotomous Data When Comparing Multiple Treatments With a Single Control
|
Shan, Guogen
|
|
|
54 |
2 |
p. 411-417
|
artikel
|
| 18 |
Global Regulatory Landscape for Aggregate Safety Assessments: Recent Developments and Future Directions
|
Ball, Greg
|
|
|
54 |
2 |
p. 447-461
|
artikel
|
| 19 |
Global Regulatory Landscape for Aggregate Safety Assessments: Recent Developments and Future Directions
|
Ball, Greg
|
|
|
54 |
2 |
p. 447-461
|
artikel
|
| 20 |
Masking in Pragmatic Trials: Who, What, and When to Blind
|
Christian, Jennifer B.
|
|
|
54 |
2 |
p. 431-436
|
artikel
|
| 21 |
MI-ND Medical Information–News Delivery: Providing Health Care Professionals With Medical Information “Proactively” by Using MessengerPeople
|
Lautner, Jürgen
|
|
|
54 |
2 |
p. 293-296
|
artikel
|
| 22 |
Notable Differences in Drug Lag Between Korea and Japan of New Drugs Between 2009 and 2017
|
Lee, Sang-Won
|
|
|
54 |
2 |
p. 418-423
|
artikel
|
| 23 |
Open Payments and the US Clinical Landscape
|
Glass, Harold E.
|
|
|
54 |
2 |
p. 390-395
|
artikel
|
| 24 |
Peptide Phage Display: Molecular Principles and Biomedical Applications
|
Zambrano-Mila, Marlon S.
|
|
|
54 |
2 |
p. 308-317
|
artikel
|
| 25 |
Peptide Phage Display: Molecular Principles and Biomedical Applications
|
Zambrano-Mila, Marlon S.
|
|
|
54 |
2 |
p. 308-317
|
artikel
|
| 26 |
Probiotics and Their Quality-Related Concerns: Highlights From the Saudi Arabian Market
|
Aldawsari, Fahad S.
|
|
|
54 |
2 |
p. 365-369
|
artikel
|
| 27 |
Quality Decision Making in Health Technology Assessment: Issues Facing Companies and Agencies
|
Bujar, Magdalena
|
|
|
54 |
2 |
p. 275-282
|
artikel
|
| 28 |
Risk of Extrapyramidal Syndromes Associated With Psychotropic Polypharmacy: A Study Based on Large-Scale Japanese Claims Data
|
Hirano, Yoko
|
|
|
54 |
2 |
p. 259-268
|
artikel
|
| 29 |
Shared Learnings on the New EMA First-in-Human and Early Clinical Trial Guideline: Proceedings From a DIAlogue Session at DIA Europe 2018
|
van der Laan, Jan Willem
|
|
|
54 |
2 |
p. 462-467
|
artikel
|
| 30 |
US Physician and Nurse Proclivity to Refer Their Patients Into Clinical Trials
|
Getz, Kenneth A.
|
|
|
54 |
2 |
p. 404-410
|
artikel
|
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