Reducing development cost of pharmaceutical drugs through risk evaluation on particle and crystalline properties
WHITE PAPER | Particle Analytical ApS
DECEMBER 05, 2016
This White Paper explores the scope of different polymorph risk evaluation scenarios and testing regimes for crystalline properties of pharmaceutical drugs and their impact on development costs.
It is intended to assist drug developers in designing the most cost-effective polymorph screening programs, being able to answer the essential question: “How much is enough?” and being able to differentiate more accurately between “nice-to-have” and “need-to-have” tests. It explores the dilemmas facing developers concerned to minimize risks of crystalline transformation of the drug substances occurring during or just after development, with huge implications for product quality, cost and patient safety.
The paper presents an optimum ‘slim screening’ solution, where the most likely scenarios are tested and enough information obtained to allow from this approach. This solution is exemplified by Particle Analytical’s specialist polymorph screening regime, which is scientifically well founded but highly focused and economical, being capable of being performed in two weeks.
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