OR WAIT null SECS
August 02, 2017
Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.
May 30, 2017
The pharmaceutical industry is making efforts by internally assessing, developing, and implementing semi-continuous manufacturing processes to improve manufacturing efficiencies.
April 02, 2017
The primary impact of using the covalidation model is the expedited analytical method qualification of both the transferring and receiving laboratories.
February 02, 2017
Although limitations must be overcome, mass spectrometry is having a great impact on biologic development and manufacturing.
Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
January 19, 2017
Researchers were not able to replicate all of the findings in five highly-cited cancer biology papers.
January 02, 2017
The authors present a set of statistical decision rules based on linear regression models that can be implemented in an automated trend system to assist stability studies.
December 07, 2016
The integration of a method validation, transfer, and verification process into the overall lifecycle management process of a product can best align the variability of the analytical procedure with the requirements of the product.
November 02, 2016
The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process.
August 02, 2016
This paper describes a unique Prep-rP-HPLC technique that uses a C-18/C-8 derivatized silica coated with a hydrophobic quaternary ammonium salt or quaternary phosphonium salt that acts as an additional/surrogate stationary phase (AsP/ssP).