USP’s Sheehan and Liu talk at AAPS PharmSci 360 abou getting novel excipients past the monograph hurdle through early engagement with FDA.
|Articles|March 1, 2002
- Pharmaceutical Technology-03-02-2002
- Volume 26
- Issue 3
Overview of Technologies Supporting Security Requirements in 21 CFR Part 11, Part II
Author(s)Orlando López
Current security technologies and associated infrastructures are designed to protect information assets and satisfy 21 CFR Part 11 requirements for integrity and privacy of records using authentication and encryption methods.
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Developing Custom Adhesive Systems for Transdermal Drug Deliveryover 24 years ago
PDA Task Force Issues Guidelines to Aid Isolator Usersover 24 years ago
Drug Safety Concerns Shape Manufacturing Policyover 24 years ago
Production Information Mangementover 24 years ago
Validation Changes to the USP Assay Method for Ibuprofen Tabletsover 24 years ago
Systematic Troubleshooting for LC/MS/MSAdvertisement
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