The FDA grants accelerated approval to subcutaneous amivantamab for head and neck cancer, extending the IV-to-subcutaneous shift in biologics formulation.
News|Articles|May 15, 2016
- Pharmaceutical Technology-05-15-2016
- Volume 2016 eBook
- Issue 2
Non-Sterile is Non-Sterile: A Reality Check on Microbial Control Expectations
Author(s)James P. Agalloco
This article discusses the issue and offers food for thought and suggestions for more science-driven approaches.
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USP requirements for the absence of “objectionable organisms” are well intended, but may often result in the need for subjective, and unrealistic, determinations. This article discusses the issue and offers food for thought and suggestions for more science-driven approaches.
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over 10 years ago
Measuring and Removing Genotoxic Impuritiesover 10 years ago
Qualification and Validation of Single-Use Shipping Systemsover 10 years ago
Lessons Learned Accelerate Vaccine Developmentover 10 years ago
Protecting the Product and the Patientover 10 years ago
Deconstructing the Regulatory SpiralAdvertisement
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USP data show fewer US drug shortages but longer ones, averaging 5+ years. Drug shortages are an incentive problem, not a manufacturing mystery.
The pharmaceutical supply chain is a complex system with high stakes. USP provides insights on how it is helping industry navigate global disruptions and procurement issues.
Mitigating nitrosamine risk requires assessing each product individually and chasing zero nitrite in pharmaceutical excipients is often impractical and costly.
Continuous overall equipment effectiveness can be used to pinpoint hidden downtime and process bottlenecks in real time.
The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of topics including formulation platforms, AI, amorphous solid dispersions, and animal studies.
Manish Baviskar, Hubot CDMO, on ALCOA++ data integrity, model version change control, continuous monitoring, and human sign-off.
The agreement between CDER and OII with allow for coordinated marketing application assessments and inspections.
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