| EXCIPIENTS AND MANUFACTURING |
Cynthia A. Challener
Taste masking increases drug acceptability and medication adherence in pediatric, geriatric, and other special patient populations.
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| FORMULATION |
Michael Morgen, Michael Grass, David Vodak
Model-based formulation and technology selection methodologies facilitate rapid product development.
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| DATA INTREGRITY |
Ron George, Thu Truong, James Davidson
Data governance is necessary for compliance with current regulatory expectations for data integrity in pharmaceutical R&D and manufacturing organizations.
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| ANALYTICAL TEST METHODS |
Alex Wheeler
Inadequate endotoxin testing places patients at risk. Knowing the relative strengths and weaknesses of available test methods is crucial to maintaining quality and safety.
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| PEER-REVIEWED RESEARCH |
Máté Mihalovits, Sándor Kemény
In Part I of this article series, the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies is investigated, and an improved approach is suggested.
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| EU REGULATORY WATCH |
Sean Milmo
The shift toward continuous manufacturing among European pharmaceutical manufacturers has not been accompanied by a similar strong increase in the use of automation and sensor-based on-line monitoring.
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| DRUG DEVELOPMENT |
Enakshi Singh
By identifying patterns, artificial intelligence and deep learning platforms help researchers discover new drugs faster.
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| OUTSOURCING OUTLOOK |
Jim Miller
Recent acquisitions are creating CDMOs with scale that rivals global bio/pharma.
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| ASK THE EXPERT |
Siegfried Schmitt
The level of formality in change control may be holding back your SOP progress, according to Siegfried Schmitt, principal consultant at PAREXEL.
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