Value-added clinical development

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. 

One way of improving the therapeutic value of physostigmine in the treatment of AD is the use of slow-release forms. Some of these are currently in clinical development. The search for cholinesterase inhibitors with longer half-lives and stronger effects led to the discovery of the aminoacridines, tacrine and its major metabolite, velnacrine maleate [Davis and Powchik... 

Once a successful value-added service has been developed, it becomes easier to develop a new service in the future. The skills necessary to evaluate the outcomes of a service can be leveraged to start a new service. Perhaps a similar service with a different disease state would be a good next step. Be careful when thinking of starting new projects that are not directly similar to the one you have implemented. For instance, the skills gained with the heart failure clinic may not apply directly to starting a compounding specialty or wound care clinic. 

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. 

Value-added versus traditional clinical development programs... 

VALUE-ADDED VS. TRADITIONAL CLINICAL DEVELOPMENT PROGRAMS... 

The information, which is compatible and shared among areas, enables a deeper understanding of each field. Yet, few medical devices with the structure to encode and share information are available. Thus, there is a necessity to develop interfaces that allow compatibility among tools and methods from different areas so that, the equipment can fully concentrate the areas involved in IPDP adding clinical and technical value besides exchanging experiences, knowledge and practices [47]. 

The clinical usefulness of MAC is questionable since, by definition, 50% of those receiving that concentration move in response to noxious stimulation. The median anaesthetic doses (ADs) required to prevent movement in 50% (AD50) and 95% (AD95) of patients are a later development and range from 5% to 40% greater than the MAC value. Again, these values are of only limited practical value. 

Three of the seven positive PIB scans (with corresponding low values of Ap42) had no symptoms of dementia. Fagan said that it is possible that these subjects have pre-dinical AD. If they develop AD, it would mean that we may have a way to screen individuals for the presence of AD pathology before the appearance of clinical symptoms. ... 

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. 

---