Reproducibility potential assays

R. Alder and H. P. Merkle, Studies on the stability of aspartame, I specific and reproducible HPLC assay for aspartame and its potential degradation products and applications to acid hydrolysis of aspartame, Pharmazie, 46 91 (1991). 

Therefore the development of synthetic phases that can offer similar recognition properties seems desirable. One promising way to introduce selectivity in chemical analysis is the use of molecularly imprinted polymers (MIPs) [14-16]. These can in favourable cases recognise small molecules with affinities and selectivites exceeding that of antibody-antigen and have, due to their robustness, capacity and reproducibility, potential as reusable adsorbents in assays or sample pretreatment. 

Protein microarrays have many potential applications in high-throughput analysis of protein function. However, simple, reproducible, and robust methods for array fabrication are required. Here we discuss the background to different routes to array fabrication and describe in detail one approach in which the purification and immobilization procedures are combined into a single step, dramatically simplifying the array fabrication process. We illustrate this approach by reference to the creation of an array of p53 variants, and discuss methods for assay and data analysis on such arrays. 

We hope that this volume will stimulate those not familiar with the power of the mouse and its potential for the drug discovery process, and further, that it wall encourage the development of new models as well as new ways in utilizing existing models. We also hope to promote the development of more standardized models and assays such that results can be more easily compared and reproduced. 

The evaluation of different chemicals involves identification of potential active agents and the mechanisms by which they present their toxic effect, prediction of effective pharmaceutical cytotoxicity for treatment of patients with cancer, evaluation of the activity range of the studied compound, identification of a target cell population and of the toxic concentration range, and the relation between pharmaceutical concentration and exposure period to reach a desired activity. The chosen assay system should provide a reproducible dose-response curve with low variability over a concentration range that includes in vivo exposure. In addition, the selected response criterion should present a linear relationship with cell number, and the information obtained with a dose-response curve should be related to the in vivo effect of the same active agent or drug. 

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