This paper presents a Python algorithm for evaluation of difference factor f1 and similarity factor f2 as a criterion for assessment of similarity between two in-vitro dissolution profiles as proposed in the EMEA and SUPAC-IR Guidance. It accelerates and facilitates the pharmaceutical developers everyday work by providing quick calculations and charts.

QA Medical Industry: Registering medical device standalone software on the EU market   Part Two In the preceding part of the article, we have tried to provide a summary of the first steps that should be taken into the certification process for a Software as a Medical Device. The successive part of the path can be […]

QA Medical Industry: Registering medical device standalone software on the EU market   Part One   In the health-care domain, over the years, software has become a pervasive technology, no longer confined to controlling traditional medical devices (e.g., radiology equipment). Medical purpose software has been assuming increasing responsibilities by redefining classic health-care services or offering […]