Analytics

Nov 16, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
Over-the-counter drug maker Perrigo Company issued a voluntary recall of certain lots of store-brand acetaminophen 500-mg caplets that could contain trace amounts of metal particulate. Approximately 11 million bottles of acetaminophen are affected by the recall.
Nov 09, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
AAPS, San Antonio (Oct. 31)-Industry and regulatory agency concerns over process variability have prompted both groups to take a closer look at analytical method transfer processes.
Nov 09, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
AAPS, San Antonio (Oct. 31-The advantages of ultra-performance liquid chromatography over traditional high-performance liquid chromatographic were the center of the presentation, ?Strategies for Rapid Chromatographic Method Development from Preclinical to Phase 3,? by Charanjeet Jassal of Wyeth Pharmaceuticals.
Nov 03, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
San Antonio, TX (Nov. 1)-Though the US Food and Drug Administration's final guidance on process analytical technology (PAT) was published in Sept. 2004, companies are still unsure about how exactly to implement PAT in their processes.
Nov 03, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
AAPS, San Antonio (Oct. 30)-Although the analysis of impurities in drug substances and drug products is not a new topic, new regulations are increasing concern in the industry.
Nov 02, 2006
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Outliers may provide useful information about the development and manufacturing process. Analysts use various statistical methods to evaluate outliers and to reduce their impact on the analysis. This article describes some of the more commonly used identification methods.
Nov 01, 2006
Pharmaceutical Technology Europe
Quality by design and PAT approaches are increasingly being used for the biotech manufacturing of medicines. Complex manufacturing processes can not only be controlled using PAT principles, but optimized with respect to both product quality and economic value. This column describes how the fermentation process is often the first to benefit from this type of implementation.
Oct 02, 2006
Special from Pharmaceutical Technology
More CMOs look to proprietary delivery technologies to enhance profitability.
Oct 01, 2006
Pharmaceutical Technology Europe
The presence of very low levels of residues (including solvents) in excipients is becoming an important issue for users, and the presence of very low levels of ?non-lactose? species in DPI lactose may pose challenges to suppliers and users.
Sep 12, 2006
ePT--the Electronic Newsletter of Pharmaceutical Technology
Washington, DC (Sept. 12)—The Office of New Drug Quality Assessment (ONDQA) in the Center for Drug Evaluation and Research (CDER) has approved one new drug application (NDA) under its CMC Pilot Program and has two more applications are under review. The pilot was established last year to provide an opportunity for FDA and industry to explore strategies for including Quality by Design (QbD) principles and process analytical technology approaches in regulatory submissions, explained ONDQA deputy director Chi-wan Chen at the PDA-FDA Joint Regulatory Conference here
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