Guidance Comments Summaries

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 ...
Posted By Linda Brown
Found In Microsite: AAPS News Magazine
Table of Contents Guidance Comments Summaries May 2016 Comments from the AAPS Ligand Binding Assay Bioanalytical Focus Group and the Therapeutic Product Immunogenicity Focus Group By Shannon Dogmanits and Joseph C. Marini Guideline on Immunogenicity ...
Posted By Linda Brown
Found In Microsite: AAPS News Magazine
Table of Contents Guidance Comments Summaries February 2018 By Rick Burdick, Henriette Kuehne, Aili Cheng, Kristof Vandekerckhove, Todd Coffey, Tara Scherder, and Katherine Giacoletti Recently, members of the AAPS Biosimilars focus group (BFG) ...