Using a Model and Tools to Standardize the Preparation for a Preapproval Inspection
Sale of Your Product Can Prevent Patenting: How to Avoid the On-Sale Bar
Outsourcing Outlook: Reaping the Benefits of E-Procurement
The Immunogenicity of Therapeutic Proteins
Analytical Advances: Calibration Management of Outsourced Calibrations
High-Throughput Biopharmaceutical Drug Development: Meeting the Coming Challenge
Inside Washington: Costs and Controls Challenge Manufacturers
21 CFR Part 11: (Un)Expected Added Value