by
Rebecca Stauffer, PDA | May 30, 2017
Below are the top ten articles from the PDA Journal of Pharmaceutical Science and Technology for the month of April.
1. 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
2. Research
Dennis Jenke, et al., “Simulated Leaching
(Migration) Study for a Model ContainerClosure
System Applicable to Parenteral and
Ophthalmic Drug Products” March/April 2017
3. PDA Paper
Stan Bukofzer, et al., “Industry Perspective on
the Medical Risk of Visible Particles in Injectable
Drug Products” January/February 2015
4. 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
5. PDA Paper
Emma Ramnarine, et al., “PDA Points To
Consider: Technical Product Lifecycle Management:
Communication and Knowledge
Exchange between Marketing Authorization
Holders and Health Authorities” March/
April 2017
6. Review
Stephen E. Langille, “Particulate Matter in
Injectable Drug Products” May/June 2013
7. Research
Paul Flaya, James D. Stamey, and John W.
Seaman, Jr., “A Bayesian Approach to Determination
of F, D, and Z Values Used in Steam
Sterilization Validation” March/April 2017
8. Research
Julie Wang, et al., “Mycoplasma Clearance
and Risk Analysis in a Model Bioprocess”
March/April 2017
9. Conference Proceeding
George Miesegaes, “Viral Clearance by Traditional
Operations with Significant Knowledge
Gaps (Session II): Cation Exchange
Chromatography (CEX) and Detergent
Inactivation” January/February 2014
10. Technology/Application
Eric C. Hilario, et al., “An Improved Method
of Predicting Extinction Coefficients for the
Determination of Protein Concentration”
March/April 2017