Drug Development

Aug 21, 2017
By Pharmaceutical Technology Editors
The first program of this collaboration will focus on the development of a candidate for severe acute pancreatitis.
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
Systems that discourage continuous improvement threaten pharma innovation, quality, and supply. Can the industry break through this deadlock?
Aug 01, 2017
Pharmaceutical Technology
Requirements for early- and late-stage trial manufacturing may differ, but complying with good practices, maintaining blind studies, and considering logistics remain crucial at all times.
Aug 01, 2017
By Pharmaceutical Technology Editors
The agency is asking for comments on a reflection paper on developing drugs for the needs of older patients.
Jul 28, 2017
By Pharmaceutical Technology Editors
The agency is asking public consultation on the concept paper.
Jul 25, 2017
By Pharmaceutical Technology Editors
The agency is offering patients with life-threatening diseases a how-to tool on accessing investigational drugs.
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