Clinical trials added value

The purification of value-added pharmaceuticals in the past required multiple chromatographic steps for batch purification processes. The design and optimization of these processes were often cumbersome and the operations were fundamentally complex. Individual batch processes requires optimization between chromatographic efficiency and enantioselectivity, which results in major economic ramifications. An additional problem was the extremely short time for development of the purification process. Commercial constraints demand that the time interval between non-optimized laboratory bench purification and the first process-scale production for clinical trials are kept to a minimum. Therefore, rapid process design and optimization methods based on computer aided simulation of an SMB process will assist at this stage. 

The derivation of data points can be conducted in a number of different ways. Usually they are calculated either in the clinical trials database or as part of the creation of the analysis ready, value added data sets. 

Audits are conducted either for a specific trial or to evaluate an entire system in clinical research and development. Both approaches are value-adding and ensure that clinical trials are conducted according to accepted principles, that trial participants are treated ethically and the trial data are valid. 

Senn SJ (2004a) Added values controversies concerning randomization and additivity in clinical trials. Statistics in Medicine 23 3729-3753. 

After the discovery of a new lead compound, a pharmaceutical company needs samples (typically, in the gram to kilogram range) of the development drug for the first clinical tests, and shortly afterward, an economical and environmentally acceptable method of synthesis for the production of larger quantities. The corresponding activity is indicated as Lead Dev. in the drug development added-value chain (see the upper line in Fig. 25.9). It precedes manufacture of the NCE for clinical trials. 

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