Particulate Matter Still a Popular Topic in the PDA Journal
Below are the top ten articles from the PDA Journal of Pharmaceutical Science and Technology for the month of April.
- PDA Paper. Deborah M. Autor, et al., “PDA Points to Consider: Best Practices for Document/Data Management and Control and Preparing for Data
Integrity Inspections,” Feb. 14, 2018 (accepted article)
- Review. Stephen E. Langille, “Particulate Matter in Injectable Drug Products,” May/June 2013
- PQRI Special Section – Research. 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
- PDA Paper. Stan Bukofzer, et al., “Industry Perspective on the Medical Risk of Visible Particles in Injectable Drug Products,” January/February 2013
- PQRI Special Section – Review. 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. Anil K. Rattan, “Data Integrity: History, Issues, and Remediation of Issues,” March/April 2018
- Technology/Application Bert Gunter, et al., “A Risk Index and Data Display for Process Performance in the Pharmaceutical Industry,” March/April 2018
- Research. Qingyu Zeng and Xia Zhao, “Time-Dependent Testing Evaluation and Modeling for Rubber Stopper Seal Performance,” March/April 2018
- Research. Benson Gikanga, Ada Hui and Yuh-Fun Maa, “Mechanistic Investigation on Grinding-Induced Subvisible Particle Formation during Mixing
and Filling of Monoclonal Antibody Formulations,” March/April 2018
- Research. Ganapathy Gopalrathnam, et al., “Impact of Stainless Steel Exposure on the Oxidation of Polysorbate 80 in Histidine Placebo and Active
Monoclonal Antibody Formulation,” March/April 2018