EMA and FDA guidance encourages design of drug products to improve patient compliance.
This article discusses fully automatic inspection of glass and plastic containers and factors that affect particle detection rate.
The authors demonstrate that a proper measure of HPMC solution concentration is its electrical conductivity rather than its viscosity.
The authors demonstrate that a proper measure of HPMC solution concentration is its electrical conductivity rather than its viscosity.
This article seeks to promote dialogue among stakeholders to facilitate consensus regarding requirements for excipients.
The authors demonstrate that a proper measure of HPMC solution concentration is its electrical conductivity rather than its viscosity.
The authors demonstrate that a proper measure of HPMC solution concentration is its electrical conductivity rather than its viscosity.
The authors demonstrate that a proper measure of HPMC solution concentration is its electrical conductivity rather than its viscosity.
This article reviews sources of excipient variability, including raw materials and processing, both of which may vary from supplier to supplier and from plant to plant for a single manufacturer.
Various impurities can infiltrate the container closure system in pharmaceutical manufacturing. Understanding nitrosamines, elemental impurities, extractables, and leachables can help ensure the safety of the final product.
Experimental work on wet granulation demonstrates the use of dynamic powder characterization to support continuous processing for tablet manufacturing.
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Preventative maintenance of heat transfer fluid systems is important for reducing downtime in pharmaceutical manufacturing.
As regulatory authorities crack down on data integrity violations, bio/pharma companies must ensure adequate data governance programs are in place.
As regulatory authorities crack down on data integrity violations, bio/pharma companies must ensure adequate data governance programs are in place.
As regulatory authorities crack down on data integrity violations, bio/pharma companies must ensure adequate data governance programs are in place.
GMP non-compliance can spill over and impact patient access to life-saving medications.
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.
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.
Traditional project decision-making is compared with a QbD approach.
Understanding the relative strengths and weaknesses of different endotoxin test methods is crucial to maintaining quality and patient safety.
Model-based formulation and technology selection methodologies facilitate rapid product development.
Innovative approaches to drug screening—such as evaluation to identify the optimal solid state of a molecule and in-vitro characterization to establish the optimal solid state of a molecule and the ideal bioavailability-enhancing technology—can help drug developers meet accelerated development timelines while managing risk.
Investing in a single source enterprise-wide LMS to fuel risk management and mitigation offers multi-dimensional return on investment.