Computerized systems are those which comprise the components shown in Figure 1.1, namely, a computer system and a controlled function which is operating within its specified working environment. The ...

Producing cGMP biopharmaceutical products requires controlled, consistent performance of the manufacturing process. cGMP also requires controlled, consistent performance of analytical test methods.

Interphex2007, New York, NY (Apr. 26)-Robustness studies for analytical methods are critical in being able to provide the assurance to the quality of an analytical method, a topic addressed in a ...

As the pace of product development accelerates, the approach to dissolution-method development must advance beyond a manual method and an assay. A natural progression of the method-development process ...

An important aspect of nonparametric regression by spline smoothing is the estimation of the smoothing parameter. In this article we report on an extensive simulation study that investigates the ...

This is a preview. Log in through your library . Abstract Fixed kernel density analysis with least squares cross-validation (LSCVh) choice of the smoothing parameter is currently recommended for ...