Thank you Allison for taking on this role! I am looking forward to continuing engagement with the regulatory community. ------------------------------ ...
Just my humble opinion, but I think we get too hung up on terminology. As I like to point out, in the GLP regulations (21CFR part 58), no where will you ...
We are excited to serve as Chair and Vice Chair of the AAPS Regulatory Science Community and look forward to building a meaningful community together. ...
Hi Joleen, We use the term 'analytically characterized'. ------------------------------ Lauren Stevenson Ph.D. Chief Scientific Officer Immunologix ...
I brought up the question about changing our language around bioanalytical and ADA assays to better align with diagnostic and clinical biomarker definitions, ...