Anti-drug Antibody Sample Testing and Reporting Harmonization - The AAPS Journal
| SpringerLink |
remove preview |
|
| Anti-drug Antibody Sample Testing and Reporting Harmonization - The AAPS Journal |
| A clear scientific and operational need exists for harmonized bioanalytical immunogenicity study reporting to facilitate communication of immunogenicity findings and expedient review by industry and health authorities. To address these key bioanalytical reporting gaps and provide a report structure for documenting immunogenicity results, this cross-industry group was formed to establish harmonized recommendations and a develop a submission template to facilitate agency filings. |
| View this on SpringerLink > |
|
|
|
To view the full article through your AAPS membership:
Go to https://www.aaps.org/education-and-research/journals/the-aaps-journal
Enter your AAPS credentials
Click "Member Access to Journals"
Click on the The AAPS Journal cover.
Copy and paste the url into the "Search" box, and click search
The full article should appear.
Follow The AAPS Journal via Twitter and LinkedIn.
------------------------------
Ho-Leung Fung Ph.D., FAAPS
Editor-in-Chief
University at Buffalo
Sarasota FL
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
------------------------------