In 2009 Stephen Bustin, together with some renowned scientists - all experts on quantitative real-time PCR (qPCR) - published a paper in Clinical Chemistry recommending a set of guidelines with some essential (59) and some desirable (28) check points for documentation of the minimum information necessary for evaluation of qPCR experiments (MIQE) 1. The paper emphasises guidelines to encourage better experimental practice, allowing more reliable and unequivocal interpretation of quantitative PCR results.
The twelve principles of Green Chemistry as formulated by Anastas and Warner (Green Chemistry: Theory and Practice, Oxford University Press: New York, 1998, p.30) guide the development of less wasteful and overall environmentally friendlier chemical manufacturing processes. The first principle states that “it is better to prevent waste than to treat or clean up waste after it has been created”.
Durbin is a worldwide specialist supplier of comparator drugs, standard of care medications and ancillary supplies for clinical trials.
Laboratoria Smeets has invested into new twin screw extrusion technology for your API’s.
Quality by Design and Design Space are concepts that have been around for quite some time in the pharmaceutical industry. Slowly the industry has warmed up to these concepts. Since the authorities provided the industry with guidelines, the interest has increased even more.
The vision of filing a Design Space is ambitious and may feel overwhelming when first pro-posed. However, over the years more and more knowledge has accumulated and the industry seems ready to take the next step. When taking this step a frequently asked question is: “How do we report the DoE part of a Design Space document internally as well as to the authori-ties?”
In Design Space projects different departments are commonly involved. Therefore a Standard Operating Procedure (SOP) to avoid errors due to misunderstandings is necessary.
This white paper will focus on the DoE part of the Design Space, and will also briefly touch on the workflow to establish before creating a successful report.