Product Development – Formulation and Matching Comparator Stability

In the development of generic drug products, it is often highly desirable to show that the stability is the same (or better) for the proposed generic formulation than for the originator.  At FreeThink, we can do side-by-side ASAPprime® studies in our laboratories to determine if indeed, the two are statistically the same.  In most cases, results can be obtained from our labs in less than six weeks.

Moreover, we often find that the originator is over-packaged, since costs for the originator are not as critical.  The team at FreeThink can determine whether the originator in its packaging can be stability-matched with the proposed generic in a less-expensive packaging option.