In our October/November issue:
PEER-REVIEWED ARTICLES
Blood Pressure Evaluation During Early Phase Trials
Daniel B. Goodman, MD, Michael A. Weber, MD
Authors present a systematic strategy for early identification of blood pressure effects during drug development, informing the need for additional testing.
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Implementation and Usage of Data Monitoring Committees
Donelle Bussom, Louise A. Winter
The key questions on how, when, and why to use a data monitoring committee in a clinical trial are answered, as well as what sourcing models for DMCs work best.
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Demonstrating Biosimilarity: PK Consideratons
Yvonne Moores
Proving pharmacokinetic “equivalence” for a biosimilar is more complex than many assume. This report highlights the special considerations needed in areas such as study design, potential immunogenicity, and relative protein contents of the test and reference drugs.
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NEWS
View From Washington: Jill Wechsler reports on the importance of R&D flexibility in combating the Ebola outbreak
View From Brussels: Peter O'Donnell on what the shakeup in the European Commission means for pharma
Global Report: Philip Ward highlights Europe's plan to standardize medical technology
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CLINICAL TRIAL INSIGHTS
‘Open Integration’ Falling Short
Ken Getz
The mix-and-match approach to integrated alliances is compromising the promise of these partnerships, research shows. |
CLOSING THOUGHT
Driving Safety and Drugs
Gary G, Kay, PhD
The technology necessary to meet expected regulatory guidance on assessing drug-impaired driving has emerged. |
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If you would like to submit an article to Applied Clinical Trials, contact Lisa Henderson, Editorial Director - [email protected]
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