Current Issue

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
FDA’s Emerging Technologies Team (ETT) team chair Sau Lee describes the reasons for the team and its structure.
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.
Aug 02, 2017
Pharmaceutical Technology
Systems that discourage continuous improvement threaten pharma innovation, quality, and supply. Can the industry break through this deadlock?
Aug 02, 2017
Pharmaceutical Technology
Amid contentious debate about “fake news,” peer-review papers offer vital, objective insight.
Aug 02, 2017
Pharmaceutical Technology
Safe and effective drug targeting with ADCs requires careful selection of drug, antibody, and linker.
Aug 02, 2017
Pharmaceutical Technology
Despite some progress, the industry is still in a wait-and-see mode regarding the administration, Congress, and FDA.
Aug 02, 2017
Pharmaceutical Technology
The review of batch records creates a story of the materials, manufacturing, and packaging involved in the production of bio/pharmaceuticals, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
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