Particulate Matter, E&L Topics of Interest to Journal Readers
Below are the top ten articles from the PDA Journal of Pharmaceutical Science and Technology for the month of February.
- Review. Stephen E. Langille, “Particulate Matter in Injectable Drug Products”
May/June 2013
- PDA Paper. Stan Bukofzer, et al. “Industry Perspective on the Medical Risk of
Visible Particles in Injectable Drug Products” January/February 2015
- Research – PQRI Special Section. Dennis Jenke, et al. “Extractables Characterization for Five Materials
of Construction Representative of Packaging Systems Used for
Parenteral and Ophthalmic Drug Products” September/October 2013
- Review – PQRI Special Section. Diane Paskiet, et al. “The Product Quality Research Institute (PQRI)
Leachables and Extractables Working Group Initiatives for Parenteral
and Ophthalmic Drug Product (PODP)” September/October 2013
- Review. Edward C. Tidswell and Tim Sandle, “Microbiological Test Data—
Assuring Data Integrity” January/February 2018
- Review. Fran L. Degrazio, “Holistic Considerations in Optimizing a Sterile Product
Package to Ensure Container Closure Integrity” January/February 2018
- Case Studies. Ana M. C. Santos, et al. “A QRM Discussion of Microbial
Contamination of Non-sterile Drug Products, Using FDA and EMA
Warning Letters Recorded between 2008 and 2016” January/
February 2018
- Research. Galen H. Shi, et al. “Impact of Drug Formulation Variables on Silicone
Oil Structure and Functionality of Prefilled Syringe System” January/
February 2018
- Research. Dennis Jenke, et al. “Simulated Leaching (Migration) Study for a
Model Container-Closure System Applicable to Parenteral and
Ophthalmic Drug Products” March/April 2017
- Research. Jeffrey R. Vieregg, “Inhibiting Sterilization-Induced Oxidation of
Large Molecule Therapeutics Packaged in Plastic Parenteral Vials”
January/February 2018