More articles from Commentary

You have access
Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS) - Through Enhanced Science and Risk-Based Approaches Industry One-Voice-of-Quality (1VQ) Solutions
Emma Ramnarine, Anders Vinther, Kimberly Bruhin, Christina Tovar and Marcello P Colao

PDA Journal of Pharmaceutical Science and Technology May 2020, pdajpst.2020.011734; DOI: https://doi.org/10.5731/pdajpst.2020.011734
You have access
Correcting the Analytical Evaluation Threshold (AET) and Reported Extractable's Concentrations for Analytical Response Factor Uncertainty Associated with Chromatographic Screening for Extractables/Leachables
Dennis Jenke

PDA Journal of Pharmaceutical Science and Technology May 2020, 74 (3) 348-358; DOI: https://doi.org/10.5731/pdajpst.2019.010520
You have access
Visible Particulate Contamination Control for Injectable Products: A Life-Cycle Approach
Stephen E. Langille

PDA Journal of Pharmaceutical Science and Technology May 2020, 74 (3) 359-366; DOI: https://doi.org/10.5731/pdajpst.2019.010462
You have access
Compendial Methods: Suitability Verification, Challenges and Recommendations for Proteins
Wen-Li Chung, Bruce Kabakoff, Jian Yin, Steven Messick, Miguel Saggu, Kate Tschudi, Rod Rahimi, Marianne Azarias and Connie Kong

PDA Journal of Pharmaceutical Science and Technology April 2020, pdajpst.2019.010652; DOI: https://doi.org/10.5731/pdajpst.2019.010652
You have access
Advancing Biologics Development Programs with Legacy Cell Lines: Advantages and Limitations of Genetic Testing for Addressing Clonality Concerns Prior to Availability of Late Stage Process and Product Consistency Data
Paul Wu, Taymar Hartman, Louise Almond, Jennitte Stevens, John Thrift, Juhi Ojha, Christina Alves, David Shaw, Michael W. Laird, Robyn Emmins, Yuan Zhu, Ren Liu, Zhimei Du, Rolf Koehler, Thomas Jostock, Karin Anderson, Chris Campbell and Howard Clarke

PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 264-274; DOI: https://doi.org/10.5731/pdajpst.2018.009316
You have access
Managing Excipient Supplier Name and Address Changes in the Pharmaceutical Quality System
Richard Rolke, Emma Ramnarine, Anders Vinther and Anil Sawant

PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 286-288; DOI: https://doi.org/10.5731/pdajpst.2019.011239
You have access
Identification and Quantitation Classifications for Extractables and Leachables
Dennis Jenke

PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 275-285; DOI: https://doi.org/10.5731/pdajpst.2019.010538
You have access
Disinfectant Efficacy: Understanding the Expectations and How to Design Effective Studies That Include Leveraging Multi-Site Data to Drive an Efficient Program
Derek Willison-Parry, Stephen Yang, Ren-Yo Forng, Tim Cirbo, Aileen Mcmeel, Brian Kiler and Christopher Phillion

PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 249-263; DOI: https://doi.org/10.5731/pdajpst.2018.009662
You have access
Steam sterilization chemical indicators are not adequate for monitoring real steam sterilization cycles
Paulo R Laranjeira, Jeane A G Bronzatti, Rafael Q Souza and Kazuko U Graziano

PDA Journal of Pharmaceutical Science and Technology March 2020, pdajpst.2019.009886; DOI: https://doi.org/10.5731/pdajpst.2019.009886
You have access
The Goldilocks Challenge-Balancing Risk When Setting Product Specifications
Richard K Burdick and Julia C O'Neill

PDA Journal of Pharmaceutical Science and Technology March 2020, pdajpst.2019.010850; DOI: https://doi.org/10.5731/pdajpst.2019.010850

Main menu

User menu

Search

More articles from Commentary

Pages

Readers

Author/Reviewer Information

Parenteral Drug Association, Inc.