Medicines clinical development

Even on a relatively small subset of reused data, it is possible to license old medicines for new therapeutic applications and greatly reduce the costs of clinical development—many of these reused medicines have already passed muster for pharmacokinetic safety, so smaller-scale clinical trials are possible, saving considerable money (e.g., Arakis—soon to become Sosei). Even Sildenafil may have new indications [39]. There are huge potential reserves of information to mine in each and every large pharmaceutical company ... 

Examples of the application of strategies based on increasing LLE or LipE and optimizing physicochemical properties as key components of medicinal chemistry programs that delivered clinical development candidates have begun to be described in the last year or so. It remains to be seen whether the hoped for reduction in compound attrition that this approach seeks to achieve will be realized, as it is early days. 

The impact of immunomodulatory protein therapeutics on diseases having unmet medical need has already proven remarkable. These new treatments have been credited with a favorable clinical profile from slowing the disease progression to outright cures. Although the cost of these advanced medicines may be offset by the enormous improvement in the quality of life of numerous patients, we must remain vigilant throughout their clinical development. 

Subsequent to the extensive medicinal chemistry exploration of Orexin antagonism, its utility in the treatment of sleep disorders in man has been reported recently. This important milestone for the therapeutic validation of the target results from the 0X1 /OX2 receptor antagonist ACT-078573 (20) [57], SB-649868 has also been announced to be in phase II clinical development, but neither the structural formula nor the results have been reported to date [58,59]. Moreover, insomnia treatments based on orexin modulation may be addressed by not only receptor antagonism but by inhibition of pathways related to the genesis of the bioactive peptides Orexin A or B, e.g. inhibition of Orexin-converting enzyme [60]. 

FIGURE 20.2. This matrix illustrates the relationship between the phases of development and types of study by objective that may he conducted during each clinical development of a new medicinal product. The shaded circles show the types of the study most usually conducted in a certain phase of development the open circles show certain types of study that may he conducted in that phase of development hut are less usual. Each circle represents an individual study. To illustrate the development of a single study, one circle is joined by a dotted line to an inset column that depicts the elements and sequence of an individual study. 

This chapter focuses on the clinical development of new medicines. This is an area where companies can plan and control much more of their activity. As more drug development projects... 

Suryawati S. Contribution of clinical pharmacology to improve the use of medicines in developing countries. Int J Risk Saf Med 2005 17 57-64. 

CPMP (2003) Points to Consider on the Clinical Development of Fibrinolytic Medicinal Products in the Treatment of Patients with ST Segment Evaluation Acute Myocardial Infarction (STEMI) ... 

Some Japanese researchers at the Kyoto University of Medicines have developed a new method for removal of large stones (mineral deposits) in kidney and bladder by using micro-explosive charges without any surgery [118-120]. Recently, applications of underwater shock waves have been extended to various clinical therapies for example, in orthopedic surgery for bone formation [121, 122], in cancer therapy, for enhancement of chemotherapeutic effects [123] and in drug delivery [124, 125]. 

The Web site ClinicalTrials.gov also provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases and conditions. The National Institutes of Health (NIH), through its National Library of Medicine, has developed this site in collaboration with all NIH institutes and the FDA. 

The field of nuclear medicine has grown tremendously in the last two decades largely as a result of the development of the Mo-99/Tc-99m generator system. The ready availability of Tc-99m created a mushrooming interest in nuclear medicine clinical and research activity. Technetium-99m in a variety of forms is annually used in millions of nuclear medicine procedures performed worldwide. During recent years there has been a significant increase in interest in very short-lived (<30 min)... 

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