Search results for " control"
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Report from India
(Dmitry Rukhlenko/Getty Images)
On July 1, India's new Drug Pricing Control Order (DPCO) 2013 replaced the 1995 version. Under this new regime, the National Pharmaceutical Pricing Pol…
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Advancing QbD in the EU
…ructured approach, which involves concepts like critical quality attributes (CQA), design space, and control strategies.
The industry has been urging EU authorities to put more emphasis in reg…
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Address the complexity of protein characterization
During development and quality control, you may use a range of analytical technologies to characterize biotherapeutic drugs in terms of their structural integrity and activity. This presentation inclu…
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In-person seminar: Manufacture of sterile medicinal products
Are you developing a Contamination Control Strategy? Join us for a free in-person seminar focused on applications at the end of the bulk drug substance workflow including drug product applicat…
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What is process development?
And if you make changes to your manufacturing process during clinical trials, this could impact regulatory CMC (chemistry, manufacturing, and controls) submissions and could have a negative effect on …
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Regulatory Requirements for Safe and Efficient Biologic Drug Development
…dealing with the health authorities, or even the quality people or the chemistry, manufacturing, and controls (CMC) people. Know your process in the out and ensure that knowledge transfers across the…
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Traceability in Western Blot Imaging: Considerations for GxP
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Densitometry analysis of gels is a key part of quality control in the pharmaceutical drug release process. In regulated environments, electronic record-keeping can improve both tra…
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Mechanistic Modeling: Current Advantages and Future Opportunities in Biopharmaceutical Process Development
This opens a wide range of model applications—from early-stage process development via process characterization to process monitoring and control.
GoSilico has developed the ChromX™ software. What…
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The Importance of Partnering for Bioanalytical Studies
A listing of assay performance characteristics, which include tables of assay control results, run summaries, and calibration curve results, are typically provided. Additional information, such as inc…
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The Evolution of Supply Chain Security: Increasing Focus on Raw Material Variability
An increase in the development of biological and patient-specific drugs has also reinforced the demand for heightened raw material control.
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