| DEVELOPMENT |
Cynthia A. Challener
FDA’s approval rate slowed, but the US agency is still ahead of its international counterparts in green-lighting new drugs for market.
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Felicity Thomas
Biologics raise unique formulation and development challenges, and industry is still on a learning curve to get the best out of these diverse and complex therapies.
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| MANUFACTURING |
Jennifer Markarian
Data collected through the Industrial Internet of Things enable predictive maintenance.
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Caroline McCormack, Chris O’Callaghan, Gareth Clarke, Ian Jones, Luke Kiernan, Gavin Walker
Advanced dynamic process control of a fluid-bed granulation process using PAT data improves product quality.
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| PEER-REVIEWED RESEARCH |
Gayatri C. Patel
The aim of this study was to prepare taste-masked drug-resin complex using ion exchange resin Kyron T-134.
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| Quality/Regulations |
James Agalloco
Past mistakes and misstatements have adversely influenced industry decontamination practices with vapor phase hydrogen peroxide, and this article endeavors to clarify the process.
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Agnes Shanley
Focusing on symptoms instead of root causes locks teams into a corrective, rather than preventive, mindset.
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| OPERATIONS |
Hallie Forcinio
Pharmaceutical companies work toward a circular economy by using sustainable packaging.
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| FROM THE EDITOR |
Rita C. Peters
The promise of new therapies is tempered by the need for affordability, safety, and ethics.
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| US REGULATORY WATCH |
Jill Wechsler
Pressures on FDA will affect industry’s success in bringing new therapies to market.
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