Novel chemical entity

In most cases, the overall synthesis time was greatly reduced (from hours or days to minutes) by switching from conventional to microwave heating, facilitating the rapid preparation of novel chemical entities. The combination of soUd-phase synthesis with microwave irradiation also allowed access to a few classes of molecules that had proven elusive via other synthetic strategies (traditional solution-phase synthesis). 

The development of a process to make a new chemical entity is not a simple procedure and a project leader will need to be appointed, if one has not been there during the speculative research phase. Process development usually costs several times more than the expenditure on the initial product research and is not entered into lightly. The procedure adopted for process development needs thoughtful planning, if time and money are not to be wasted. The procedure, which is described here, is normally applied to novel chemical entities, but many of the aspects apply equally to the addition of a known material to a company s selling range. 

Based on the previous knowledge about the properties of novel chemical entity obtained during the late discovery and nomination, the stability studies of API are performed based on ICH guidance [43]. 

Chemical Biology encompasses more aspects than the development of novel high-affinity ligands for targets of pharmaceutical interest alone. However, if the latter is understood as the art of developing novel chemical entities toward new drugs. 

Fig. 1 Reasons for termination of research on novel chemical entities (NCEs). Data taken from information on new compounds taken into clinical trials by seven major UK pharmaceutical companies (1964—1985).

Category 3b novel chemical entity or placebo controlled study... 

Considerable effort has been expended in the pharmaceutical industry worldwide to capitalize on this approach with significant successes that have enhanced the search for novel chemical entities as well as providing research tools to better understand receptor and enzyme function. 

The success of the pharmaceutical industry depends largely on the synthesis and screening of novel chemical entities and their ability to optimize selected leads into marketable drugs. In a market where development costs are exceptionally high, the ability to shorten optimization times would be desirable to reduce this cost. Furthermore, new technology that would enable a cost-effective upward step-change in the number of lead candidates that could be prepared would provide an obvious competitive advantage, as this would potentially enable the discovery of a better lead with enhanced therapeutic properties, with reduced side effects. 

Louden, C., and D. G. Morgan. 2001. Pathology and pathophysiology of drug-induced arterial injury in laboratory animals and its implications on the evaluation of novel chemical entities for human clinical trials. Pharmacology and Toxicology 89 158-170. 

Before any novel chemical entities are screened in the primary assay, known compounds and controls from many classes of drugs, known as pharmacophores, are often tested in the assay. This will provide a set of controls, both negative and positive, for developing new compounds based on chemical structures. Pharmacophores are often... 

In addition, the number of hospital-acquired life-threatening infections has been steadily increasing in the past decades. Thus, great efforts are being undertaken in the search for novel chemical entities with antibacterial activity and possibly novel modes of action. 

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