Welcome Message We are honored to serve as Chair and Vice Chair of this Pharmaceutical Quality Community (PQC) and are excited to build a dynamic, supportive, ...
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 ...