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PDA Journal of Pharmaceutical Science and Technology|November 23, 2013
Enabling ICH Q10 Implementation--Part 1. Striving for Excellence by Embracing ICH Q8 and ICH Q9Nuala Calnan, Kevin O'Donnell, Anne Greene
PDA Journal of Pharmaceutical Science and Technology|November 23, 2013
A Risk-based Approach to Setting Sterile Filtration Bioburden LimitsHarry Yang, Na Li, Stephen Chang
PDA Journal of Pharmaceutical Science and Technology|November 23, 2013
Comparison of different fungal agar for the environmental monitoring of pharmaceutical-grade cleanroomsBarbara Gebala, Tim Sandle
PDA Journal of Pharmaceutical Science and Technology|November 23, 2013
High-voltage leak detection of a parenteral proteinaceous solution product packaged in form-fill-seal plastic laminate bags. Part 2. Method performance as a function of heat seal defects, product-package refrigeration, and package plastic laminate lotMats Rasmussen, Rasmus Damgaard, Peter Buus, et al.
PDA Journal of Pharmaceutical Science and Technology|November 23, 2013
High-Voltage Leak Detection of a Parenteral Proteinaceous Solution Product Packaged in Form-Fill-Seal Plastic Laminate Bags. Part 3. Chemical Stability and Visual Appearance of a Protein-Based Aqueous Solution for Injection as a Function of HVLD ExposureMats Rasmussen, Rasmus Damgaard, Peter Buus, et al.
PDA Journal of Pharmaceutical Science and Technology|November 23, 2013
Development of an inductively coupled plasma mass spectrometry method for quantification of extracted tungsten from glass prefilled syringes used as a primary packaging for pharmaceutical and therapeutic protein productsKiyoshi Fujimori, Hans Lee, Joseph Phillips, et al.
PDA Journal of Pharmaceutical Science and Technology|September 5, 2014
Meeting report-workshop on spike characterizations and virus removal by filtration: trends and new developmentsHannelore Willkommen, Johannes Blümel, Kurt Brorson, et al.
PDA Journal of Pharmaceutical Science and Technology|January 23, 2016
Investigation of Air-Liquid Interface Rings in Buffer Preparation Vessels: the Role of Slip AgentsTing Shi, Wei Ding, Donald W Kessler, et al.
PDA Journal of Pharmaceutical Science and Technology|January 23, 2016
A Bayesian Approach to Residual Host Cell DNA Safety AssessmentHarry Yang, Jianchun Zhang
PDA Journal of Pharmaceutical Science and Technology|March 30, 2016
Retrospective Evaluation of Low-pH Viral Inactivation and Viral Filtration Data from a Multiple Company CollaborationJohn Mattila, Mike Clark, Shengjiang Liu, et al.
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