More articles from RESEARCH

You have access
Worldwide Regulatory Reliance: Launching a Pilot on a Chemistry, Manufacturing, and Control Post Approval Change for a Vaccine
Thierry Gastineau, Cynthia Ban, Ana Basso, Franziska Brehme, Ana Luisa Silva, Olivier Faure, Lyne Le Palaire, Priya Persaud and Heraclio Rodriguez

PDA Journal of Pharmaceutical Science and Technology July 2024, 78 (4) 388-398; DOI: https://doi.org/10.5731/pdajpst.2023.012850
You have access
Comparison of Excipients in Approved Parenteral Products and Their Maximum Daily Exposure Values
Miha Homar, Špela Kalčič and Gorazd Gorup

PDA Journal of Pharmaceutical Science and Technology July 2024, 78 (4) 445-464; DOI: https://doi.org/10.5731/pdajpst.2022.012782
You have access
Sensitization Assessment of Extractables and Leachables in Pharmaceuticals: ELSIE Database Analysis
Patricia Parris, Geraldine Whelan, Anders Burild, Jessica Whritenour, Uma Bruen, Joel Bercu, Courtney Callis, Martyn L. Chilton, Jessica Graham, Esther Johann, Candice Johnson, Troy Griffin, Martin Kohan, Elizabeth A. Martin, Melisa Masuda-Herrera, Brad Stanard, Maureen T. Cruz and Lee Nagao

PDA Journal of Pharmaceutical Science and Technology July 2024, 78 (4) 399-444; DOI: https://doi.org/10.5731/pdajpst.2022.012811
You have access
Impact of NaCl on Monoclonal Antibody Aggregation Induced by Agitation
Justin K.Y. Hong, Wei Liu and Kai Zheng

PDA Journal of Pharmaceutical Science and Technology July 2024, 78 (4) 465-474; DOI: https://doi.org/10.5731/pdajpst.2023.012860
You have access
Establishment of a Single Temperature Incubation Approach for Environmental Monitoring Samples with Focus on Mold Recoveries
Alana Poloni, Janete GonÇalves, MÓnica Pereira and Alexander Stoll

PDA Journal of Pharmaceutical Science and Technology May 2024, 78 (3) 312-330; DOI: https://doi.org/10.5731/pdajpst.2022.012769
You have access
In Silico Assessment of Biomolecule Reactivity with Leachables
Candice Johnson, Douglas Kiehl, Piet Christiaens, Ferran Sancho Jodar, Ruud Cuyvers, Arianna Bassan, Lisa Beilke, Joel P. Bercu, Thomas Costelloe, Kevin P. Cross, Andrew Feilden, Ron Filler, Maria Fátima Lucas, Melisa J. Masuda-Herrera, Mona Moghimi, Nick Morley, Diane Paskiet, Manuela Pavan, Julia Pletz, M. Vijayaraj Reddy, Christopher J. Waine and Glenn J. Myatt

PDA Journal of Pharmaceutical Science and Technology May 2024, 78 (3) 214-236; DOI: https://doi.org/10.5731/pdajpst.2022.012818
You have access
Characterizing Extractables and Leachables Chemical Space to Support In Silico Toxicological Hazard Assessments
Candice Johnson, Arianna Bassan, Doug Kiehl, Diane Paskiet, Manuela Pavan, Patricia Parris, Geraldine Whelan, Anders Burild and Glenn J. Myatt

PDA Journal of Pharmaceutical Science and Technology May 2024, 78 (3) 237-311; DOI: https://doi.org/10.5731/pdajpst.2022.012819
You have access
Creating an Assessment Indicator of Quality Culture Development in the Generic Pharmaceutical Industry in Japan
Shiho Takahashi, Tetsuhito Takarada, Riho Kitamura, Mayumi Shikano and Shingou Sakurai

PDA Journal of Pharmaceutical Science and Technology January 2024, 78 (1) 45-69; DOI: https://doi.org/10.5731/pdajpst.2022.012824
You have access
Modeling the Migration Behavior of Extractables from Mono- and Multilayer Polyolefin Films to Mathematically Predict the Concentration of Leachable Impurities in Pharmaceutical Drug Products. Part 1: Experimental Details and Modeling Experimental Results
Peter V. Mercea, Manfred Ossberger, Regina Wyrwich, Matthias Herburger, Vishal Barge, Rajendra Aluri and Valer Toşa

PDA Journal of Pharmaceutical Science and Technology January 2024, 78 (1) 3-32; DOI: https://doi.org/10.5731/pdajpst.2022.012816
You have access
Modeling the Migration Behavior of Extractables from Mono- and Multilayer Polyolefin Films to Mathematically Predict the Concentration of Leachable Impurities in Pharmaceutical Drug Products. Part 2: Conservative Diffusion and Partition Coefficient Determinations
Peter V. Mercea, Manfred Ossberger, Regina Wyrwich, Matthias Herburger, Vishal Barge, Rajendra Aluri and Valer Toşa

PDA Journal of Pharmaceutical Science and Technology January 2024, 78 (1) 33-44; DOI: https://doi.org/10.5731/pdajpst.2022.012817

Main menu

User menu

Search

More articles from RESEARCH

Pages

Readers

Author/Reviewer Information

Parenteral Drug Association, Inc.