ATG Scientific, in conjunction with Amebis Ltd, is now offering the ASAPprime software package that enables pharmaceutical scientists to rapidly and accurately perform shelflife studies of drug substance and drug product shelflife using the Accelerated Stability Assessment Program (ASAP) approach.
ASAPprime uses much more advanced science and statistics compared with existing ICH methodology, allowing predictions of shelflife to be completed in just two to four weeks versus two to six months for ICH.
ASAPprime provides an extremely robust and multidimensional analysis for estimating stability and the optimal combination of packaging, formulation, ingredient supplier and manufacturing process, without the need for repeated and lengthy laboratory studies. This means that better and faster decisions can be made in development operations, thereby eliminating unnecessary costly reformulations and process changes.
ASAPprime also helps make regulatory packages more robust by providing scientific rationale for decisions.
ATG Scientific Ltd, +44 1865 261423, enquiries@atgscientific.co.uk, www.atgscientific.co.uk.