Patricia Van Arnum was executive editor of Pharmaceutical Technology.
Delivering Complex Parenteral Formulations
November 12th 2013Progress in delivery science, manufacturing technologies, and commercialization are playing critical roles in advancing the development of complex parenteral drug formulations for new drug substances having a variety of formulation challenges
Regulatory and QA/QC Focus Elemental Impurity Analysis
October 28th 2013As the pharmaceutical industry prepares for changes to compendial and regulatory standards for elemental impurity analysis, QA/QC and laboratory scientists are tasked with adapting their operations to include data management, analysis, and reporting based on inductively coupled plasma–mass spectrometry (ICP–MS).
Preparing for Regulatory Inspections
October 28th 2013Regulatory compliance is of paramount importance to pharmaceutical and biopharmaceutical companies, which must be continually prepared for inspections by FDA, EMA, and other health authorities to meet requirements for good clinical practices (GCP) and good manufacturing practices (GMP).