The FDA approves oral pritelivir for drug-resistant herpes sores in immunocompromised patients; what it means for antiviral development and manufacturing.
News|Articles|September 18, 2019
Pharmacopoeia Compliance Series
In this series of articles, J. Mark Wiggins, owner and compendial consultant with Global Pharmacopoeia Solutions LLC, and Joseph A. Albanese, director of Analytical Strategy and Compliance at Janssen Research and Development, LLC, provide an understanding about the need for pharmacopoeia compliance.
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In this series of articles, J. Mark Wiggins, owner and compendial consultant with Global Pharmacopoeia Solutions LLC, and Joseph A. Albanese, director of Analytical Strategy and Compliance at Janssen Research and Development, LLC, provide an understanding about the need for pharmacopoeia compliance.
The following articles can be found within this series:
Why Pharmacopoeia Compliance is Necessary
Why Pharmacopoeia Compliance is Difficult
A Brief History of Pharmacopoeias: A Global Perspective
Global Pharmacopoeia Standards: Why Harmonization is Needed
Harmonization Efforts by Pharmacopoeias and Regulatory Agencies
Revision Process for Global/National Pharmacopoeias
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Surveillance Process for Industry: Monitoring Pharmacopoeia Revisions
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Monograph Development: Why and When to Participate
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Monograph Development: How to Participate; How to Harmonize
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A Practical Approach to Pharmacopoeia Compliance
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A Case Study in Pharmacopoeia Compliance: Excipients and Raw Materials
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Pharmacopoeia Compliance: Putting it All Together; What is on the Horizon
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