July 27, 2015 A framework for donor and recipient companies to jointly analyze and document the technical and business risks associated with a technical transfer
To help drive the tech transfer of partner products, Alkermes sought to develop a risk assessment f…
Stephanie Mowery, Sherri Rinker, Franklin Spriggs and Bo Kowalcyk , AIT Bioscience || June 2, 2015 Moving forward clinical studies will have to include a comparative assessment of
pharmacokinetics and immunogenicity to the original reference biologic drug
Alex McClung, Xcelience || November 13, 2014 Getting packaged investigational materials dispensed to the patients taking part in clinical trials, on time and correctly, requires orchestrating myriad activities. This is the second in a series of articles outlining specific quality concerns associated with packaging clinical trial supplies and how to effectively manage those concerns.