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PDA Journal of Pharmaceutical Science and Technology|November 17, 2020
The Implications of Chromatographically Screening Medical Products for Organic Leachables Down to the Analytical Evaluation Threshold Adjusted for Response Factor VariationDennis Jenke, Ted Heise
PDA Journal of Pharmaceutical Science and Technology|October 17, 2020
Quantifying Operator Subjectivity within Flow Cytometry Data Analysis as a Source of Measurement Uncertainty and the Impact of Experience on ResultsRebecca Grant, Karen Coopman, Nicholas Medcalf, et al.
PDA Journal of Pharmaceutical Science and Technology|March 18, 2020
Determining the Clearance of Degraded Protein via a Monoclonal Antibody Purification Process in Support of Cleaning Carryover Limits in Multiproduct FacilitiesPao Lin Che, Alison P Bailey, Chi Yan J Tam, et al.
PDA Journal of Pharmaceutical Science and Technology|January 15, 2022
Development of Duration-Based Non-Mutagenic Thresholds of Toxicological Concern (TTCs) Relevant to Parenteral Extractables and Leachables (E&Ls)Melisa J Masuda-Herrera, Joel P Bercu, Thomas H Broschard, et al.
PDA Journal of Pharmaceutical Science and Technology|January 15, 2022
Systematic Design, Generation, and Application of Synthetic Datasets for Flow CytometryMelissa Cheung, Jonathan J Campbell, Robert J Thomas, et al.
PDA Journal of Pharmaceutical Science and Technology|December 16, 2021
Proceedings of the 2019 Viral Clearance Symposium, Session 7: Cell Banks and U.S. PharmacopeiaSean O'Donnell
PDA Journal of Pharmaceutical Science and Technology|December 16, 2021
Proceedings of the 2019 Viral Clearance Symposium, Session 8. Conference Summary: Key Discussion and Outcomes, Pending Questions, and Proposed Experiments and ActionsGlen Bolton
PDA Journal of Pharmaceutical Science and Technology|February 20, 2021
Hot-Melt Extrusion: An Emerging Technique for Solubility Enhancement of Poorly Water-Soluble DrugsAmit Chivate, Atul Garkal, Namdev Dhas, et al.
PDA Journal of Pharmaceutical Science and Technology|February 20, 2021
Statistically Significant versus Practically Relevant Trend in Stability DataBernhard Schmelzer, AndrÉ Mischo, Franz Innerbichler
PDA Journal of Pharmaceutical Science and Technology|February 20, 2021
Challenges in the Manual Visual Inspection of the Interior Surfaces of Single-Use Systems for the Presence of Particulate MatterKlaus Wormuth, Olivier Benoit, Dounia Kateb, et al.
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