Blinding properties of methods for supplying drug kits to investigational sites.

Most blinded, late stage, randomized clinical trials package study drug, active or placebo, into drug kits for distribution to investigational sites. Drug kits enable investigators to administer study drug to subjects in a blinded manner without the assistance of an unblinded pharmacist. Supply methods determine when and how many kits to send to sites.

The other randomization - methods for labeling drug kits.

Purpose: Most phases 2 and 3 blinded randomized clinical trials package study drug, e.g., active and placebo, into drug kits for distribution to investigational sites.

Utilizing design of experiments to characterize assay robustness.

Background: Design of experiments (DOE) is a systematic approach to assess the effects of many factors on a response of an assay. This paper provides a case study whereby DOE was successfully utilized to evaluate robustness parameters for a ligand-binding assay (LBA).

Methodology: A 24-run Plackett-Burman design was developed to investigate factors that may have caused a lack of robustness in this particular LBA.

Compound classification using image-based cellular phenotypes.

Compounds with similar target specificities and modes of inhibition cause similar cellular phenotypes. Based on this observation, we hypothesized that we could quantitatively classify compounds with diverse mechanisms of action using cellular phenotypes and identify compounds with unintended cellular activities within a chemical series. We have developed Cytometrix technologies, a highly automated image-based system capable of quantifying, clustering, and classifying changes in cellular phenotypes for this purpose.