USP is convening a virtual workshop on April 30 to advance a compendial framework for mutagenic impurities (MI) - if mutagenic impurities are part of ...
Please find attached my comments and article on Practical Example of Product Development in the Firm's ANDA (Case History): Back in 2010, ...
Thank you, @Bruno Hancock , for flagging this timely FDA initiative. SUPAC guidance sits at the intersection of formulation design, scale‑up, CMC, analytical/bioanalytical ...
ICH just released a presentation on "M15: General Principles for Model-Informed Drug Development" It provides an overview of M15 and notes several times ...
The FDA is seeking feedback on the SUPAC guidelines that apply to manufacturing process changes upon scale-up. Presumably members of this community might ...