Finished Product Analysis

Jul 19, 2018
By Pharmaceutical Technology Editors
The agency has issued a warning letter for cGMP violations at a drug manufacturing facility in Ahmedabad, India, that Baxter gained through its acquisition of Claris Injectables.
Jun 02, 2018
Pharmaceutical Technology
Flow imaging microscopy can be used to identify particulates and their sources.
Mar 02, 2018
Pharmaceutical Technology
Stability testing on APIs/finished drug product helps define optimal drug packaging for shelf-life storage.
Feb 02, 2018
Pharmaceutical Technology
X-ray powder diffraction exploits the interaction between x-rays and matter to study the structural and microstructural properties of materials.
Dec 05, 2017
By Pharmaceutical Technology Editors
Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.
Dec 02, 2017
Pharmaceutical Technology
In Part I of this article series, the authors discussed the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies. In Part II, the by-time-point method and the multivariate control chart method are investigated, and improved approaches are suggested. The method is illustrated using real data sets.
Nov 02, 2017
Pharmaceutical Technology
In Part I of this article series, the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies is investigated, and an improved approach is suggested.
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