Analytical Method Development

Sep 02, 2017
Pharmaceutical Technology
Forced degradation studies can identify stability problems for drug substance and drug products.
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.
May 30, 2017
The pharmaceutical industry is making efforts by internally assessing, developing, and implementing semi-continuous manufacturing processes to improve manufacturing efficiencies.
Apr 02, 2017
Pharmaceutical Technology
The primary impact of using the covalidation model is the expedited analytical method qualification of both the transferring and receiving laboratories.
Feb 02, 2017
Pharmaceutical Technology
Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
Feb 02, 2017
Pharmaceutical Technology
Although limitations must be overcome, mass spectrometry is having a great impact on biologic development and manufacturing.
Jan 19, 2017
Researchers were not able to replicate all of the findings in five highly-cited cancer biology papers.
Jan 02, 2017
Pharmaceutical Technology
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.
Dec 07, 2016
PTSM: Pharmaceutical Technology Sourcing and Management
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.
Nov 02, 2016
Pharmaceutical Technology
The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process.
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