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.
Jul 21, 2017
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
Contract manufacturers await a promising pipeline of drug products to jump-start stagnant growth.
Jul 19, 2017
The new label-free method for quantifying intracellular bioavailability can be used to predict drug exposure to target cells and hence its efficacy.
Jul 18, 2017
By Pharmaceutical Technology Editors
Researchers have demonstrated how an investigational drug currently in testing works against Niemann-Pick type C1, which may lead to treatments for other similar disorders.
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