Five open access white papers were recently published in AAPS journals.
In 2017, the American Association of Pharmaceutical Scientists (AAPS), in partnership with Springer Nature, published five open access white papers. The pharmaceutical science community can read and share these freely available articles that provide important recommendations and best practices. Learn more about each of the white papers below.
Recommended Best Practices for Process Monitoring Instrumentation in Pharmaceutical Freeze Drying—2017
By Steven Nail, Serguei Tchessalov, Evgenyi Shalaev, et al
AAPS PharmSciTech
“Recommended best practices in monitoring of product status during pharmaceutical freeze drying are presented, focusing on methods that apply to both laboratory and production scale.”
Approaches for Establishing Clinically Relevant Dissolution Specifications for Immediate Release Solid Oral Dosage Forms
By Andre Hermans, Andreas M. Abend, Filippos Kesisoglou, et al
The AAPS Journal
“The intent of this manuscript is to highlight the challenges of, and to provide a recommendation on, the development of clinically relevant dissolution specifications (CRS) for immediate release (IR) solid oral dosage forms.”
Recommendations for Selection and Characterization of Protein Biomarker Assay Calibrator Material
By Kyra J. Cowan, Lakshmi Amaravadi, Mark J. Cameron, et al
The AAPS Journal
“Several case studies are presented that demonstrate some of the challenges involved in selecting appropriate calibrators along with the resolutions that were ultimately applied.”
Drug Target Interference in Immunogenicity Assays: Recommendations and Mitigation Strategies
By Zhandong Don Zhong, Adrienne Clements-Egan,
Boris Gorovits, et al
The AAPS Journal
“This publication describes various mechanisms of assay interference by soluble drug target, as well as strategies to recognize and mitigate such target interference.”
Recommendations for the Assessment and Management of Pre-existing Drug-Reactive Antibodies During Biotherapeutic Development
By Li Xue, Adrienne Clements-Egan, Lakshmi Amaravadi, et al
The AAPS Journal
“This paper describes how the immunogenicity risk assessment of a biotherapeutic integrates the existence of pre-existing drug-reactive antibodies, and provides recommendations for risk-based strategies to evaluate treatment-emergent ADA responses.”
Check out more white papers published in AAPS journals in 2018. Remember that all AAPS Open articles are freely available!