Drug Development

Aug 15, 2017
By Pharmaceutical Technology Editors
Catalent Applied Drug Delivery Institute (CADDI) announced that Jim Spavins, a veteran pharmaceutical industry executive, has joined the institute’s advisory board.
Aug 14, 2017
By Pharmaceutical Technology Editors
The private investment firm’s $110-million acquisition boosts its API and finished dosage form value chain.
Aug 10, 2017
By Pharmaceutical Technology Editors
Cambrex is investing $24 Million in new, highly potent API manufacturing capacity at its Charles City, Iowa site.
Aug 07, 2017
By Pharmaceutical Technology Editors
Lonza further expands its micronization services with the acquisition of Swiss contract manufacturer, Micro-Macinazione, following its previous $5.5-billion acquisition of dosage form provider, Capsugel.
Aug 07, 2017
By Pharmaceutical Technology Editors
Featuring software, parallel automated reactors, and other tools designed to facilitate design of experiments, development of the design space, and better process understanding and control, the Hyderabad facility came online on July 20
Aug 02, 2017
Pharmaceutical Technology
EMA recognizes the need to provide more assistance and guidance to SMEs developing new medicines and applying for marketing authorizations.
Aug 02, 2017
Pharmaceutical Technology
Statistical methods and novel indices can be used to monitor and benchmark variability, and guide continuous improvement programs in late-stage drug development.
Aug 02, 2017
Pharmaceutical Technology
The author describes how to establish acceptance limits for acceptance value (AV) data for process validation batches, typical characteristics of AV distributions, and how to derive relevant constants for AV control charts in annual product review and continued process verification reports.
Aug 02, 2017
Pharmaceutical Technology
Lawrence Yu, Deputy Director, Office of Pharmaceutical Quality at FDA’s Center for Drug Evaluation and Research (CDER), shares insights with Pharmaceutical Technology.
Aug 02, 2017
Pharmaceutical Technology
Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.
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