Guidance Comments Summaries

Posted By Matt Baughman
Found In Microsite: AAPS News Magazine
By Henriette Kuehne, Kristof Vandekerckhove, Carol Kirchhoff   On December 12, 2018, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance for industry titled New and Revised Draft Q&As on Biosimilar Development ...
Posted By Linda Brown
Found In Microsite: AAPS News Magazine
By Kayla J. Spivey Published on January 16, 2019, Immunogenicity Testing of Therapeutic Protein Products—Developing and Validating Assays for Anti-Drug Antibody Detection represents the first signed version of immunogenicity-specific guidance by the ...
Posted By Linda Brown
Found In Microsite: AAPS News Magazine
By Alger Salt, Sal Mia Consulting The In Vitro Release and Dissolution Testing Community (IVRDTC) is currently in a state of transition from the focus group (In Vitro Release and Dissolution Testing focus group) that was formed in 2005.  Our community ...
Posted By Linda Brown
Found In Microsite: AAPS News Magazine
Table of Contents Guidance Comments Summaries March 2016 Comments from the AAPS In Vitro Release and Dissolution Testing focus group. By Gregory Martin Dissolution Testing and Specification Criteria for Immediate-Release Solid Oral Dosage Forms ...
Posted By Linda Brown
Found In Microsite: AAPS News Magazine
AAPS Newsmagazine Online welcomes timely summaries of recent comments on draft regulatory guidances such as those published on the U.S. Pharmacopeial Convention, the Food and Drug Administration, or international regulatory websites. If you wish to write ...