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December 2017 What's at Stake with HBELs

November 2017 Toxicity as a Worst-Case Grouping Factor

October 2017 Meaning of "Dedicated"?

September 2017 Another Issue for API Synthesis

August 2017 EMA's Q&A Clarification: Part 2

July 2017 EMA's Q&A Clarification: Part 1

June 2017 Pass/Fail Analytical Test Methods

May 2017 Issues in Product Grouping

April 2017 Dirty and Clean Hold Time Protocols

March 2017 Establishing Clearance for Degraded Protein Actives

February 2017 A Possible Approach for Biotech Limits

January 2017 A Critique of the APIC Guideline