More articles from TECHNOLOGY/APPLICATION

You have access
Is Retention Time and/or Structure Matching a Solution to the Challenge of Providing Quantitative Data when Screening for Extractables and Leachables by GC/MS?
Dennis Jenke, Piet Christiaens, Philippe Verlinde, Jan Baeten and Jean-Marie Beusen

PDA Journal of Pharmaceutical Science and Technology November 2021, pdajpst.2021.012673; DOI: https://doi.org/10.5731/pdajpst.2021.012673
You have access
Statistical Method for Trending of Excursions in Clean Room Microbiological Monitoring Data
K. Rao Gurijala and Andrew Barnett

PDA Journal of Pharmaceutical Science and Technology September 2021, 75 (5) 407-424; DOI: https://doi.org/10.5731/pdajpst.2020.011791
You have access
Statistical Quality and Process Control in Biopharmaceutical Manufacturing—Practical Issues and Remedies
Nicolas Heigl, Bernhard Schmelzer, Franz Innerbichler and Mahesh Shivhare

PDA Journal of Pharmaceutical Science and Technology September 2021, 75 (5) 425-444; DOI: https://doi.org/10.5731/pdajpst.2020.011676
You have access
100% Control of Controlled Ice Nucleation Vials by Camera-Supported Optical Inspection in Freeze-Drying
Julian Hendryk Gitter, Raimund Geidobler, Werner Halbinger, Ingo Presser and Gerhard Winter

PDA Journal of Pharmaceutical Science and Technology June 2021, pdajpst.2020.012575; DOI: https://doi.org/10.5731/pdajpst.2020.012575
You have access
The Implications of Chromatographically Screening Medical Products for Organic Leachables Down to the Analytical Evaluation Threshold Adjusted for Response Factor Variation
Dennis Jenke and Ted Heise

PDA Journal of Pharmaceutical Science and Technology May 2021, 75 (3) 273-288; DOI: https://doi.org/10.5731/pdajpst.2020.012013
You have access
Development of Generic Equivalence Margins for Early-Stage Implementation of Equivalence Testing for Potency Assays
Thorsten Pflanzner, Yuanyuan Duan, Uyentrang N. Bui, Lanju Zhang, Stephen E. Hartman and Martina Kron

PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 173-187; DOI: https://doi.org/10.5731/pdajpst.2020.012096
You have access
Container Closure Integrity Test Using Frequency Modulation Spectroscopy Headspace Analysis with Carbon Dioxide as a Tracer Gas
Allison Alix Caudill, Ken Victor, Michael Timmins and James Veale

PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 157-172; DOI: https://doi.org/10.5731/pdajpst.2020.011502
You have access
Risk Mitigation of Drug Shortages—A New Concept for Vials Designed to Improve Fill and Finish Performance
Holger Roehl, Stephanie Mangold, Florian Maurer and Diana Loeber

PDA Journal of Pharmaceutical Science and Technology March 2021, 75 (2) 141-156; DOI: https://doi.org/10.5731/pdajpst.2020.011585
You have access
Artificial Intelligence Algorithm Qualification: A Quality by Design Approach to Apply Artificial Intelligence in Pharma
Toni Manzano, Cristina Fernàndez, Toni Ruiz and Hugo Richard

PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 100-118; DOI: https://doi.org/10.5731/pdajpst.2019.011338
You have access
Knowledge Management as a Pharmaceutical Quality System Enabler: How Enhanced Knowledge Transfer Can Help Close the ICH Q10 to ICH Q12 Gap
Martin J. Lipa, Anne Greene and Nuala Calnan

PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 64-90; DOI: https://doi.org/10.5731/pdajpst.2020.011825

Main menu

User menu

Search

More articles from TECHNOLOGY/APPLICATION

Pages

Readers

Author/Reviewer Information

Parenteral Drug Association, Inc.