New medicines

The approval of a new drug requires preclinical and chnical studies and takes an average of 10 years to complete. The preclinical and chnical trials have to prove the safety and efficacy of every new medicine. 

Nobel-laureate Richard Feynman once said that the principles of physics do not preclude the possibility of maneuvering things atom by atom (260). Recent developments in the fields of physics, chemistry, and biology (briefly described in the previous sections) bear those words out. The invention and development of scanning probe microscopy has enabled the isolation and manipulation of individual atoms and molecules. Research in protein and nucleic acid stmcture have given rise to powerful tools in the estabUshment of rational synthetic protocols for the production of new medicinal dmgs, sensing elements, catalysts, and electronic materials. 

It is one of the peculiarities of herbal drugs that their indications have for the most part been determijied empirically. The reason is easily understood most herbal drugs have been used for a very long time to alleviate or cure illnesses and more especially disorders. Their introduction in therapeutics happened at a time when pharmacodynamics and pharmacokinetics were unknown concepts, when there was no Medicines Act to require proof of the quality, efficacy, and innocuity of herbal medicines. Today, when introducing a new medicine, extensive investigations are required in the interest of safety. To many the requirement of the proof of activity of such a drug as chamomile appears to be superfluous, but nevertheless, as a representative of a scientifically oriented pharma-... 

Fig. 13-2. Establishing procedures for chiral new drug substances and new medicinal products containing new chiral drug substances.

The guideline on impurities in new medicinal products parallels the drug substance text, but the designated thresholds concern only degradation products. The thresholds should be applied to the product at the end of its shelf-life, as that is when the greatest level of degradation is expected to have occurred. 

Still other halo-substituted compounds are providing important leads to new medicines. The compound epihatidine, for instance, has been isolated from the skin of Ecuadorian frogs and found to be more than 200 times as potent as morphine at blocking pain in animals. 

In conclusion, the discovery of incretins has now come to an end in terms of therapeutic strategy of metabolic diseases since new medicines will be put on the market these coming years. However, a lot more needs to be done with regard to the physiological role of the hormones. Whereas the major filed of investigation for GLP-1 now relates to the effect of the peptide on the central nervous system and on (3-cell proliferation, for GIP it remains to understand its role in the numerous tissues where the corresponding receptor is expressed. 

GL39 Quality specifications Test Procedures and Acceptance Criteria for new Veterinary Drug Substances and New medicinal Products Chemical Substances... 

More recently, a group in England led by a structural biologist compiled a list of marketed medicines that came from SBDD [133]. These are labeled SBDD in Table 1.2. It can be seen that there is only a little overlap between the two compilations (CADD and SBDD). It can also be seen that the number of pharmaceuticals from SBDD is very impressive. Computer-based technologies are clearly making a difference in helping bring new medicines to patients. 

Improving scientific productivity is not simply down to information management alone. Nor is knowledge management alone going to increase the number of new medicines reaching the marketplace. Standards initiatives are only driven by the need to avoid chaos and reduce data loss, not by compliance or... 

DiMasi JA. The value of improving the productivity of the drug development process faster times and better decisions. In The cost and value of new medicines in an era of change. Pharmacoeconomics 2002 20(Suppl 3) 1-10. 

Although, as stated at the beginning of this chapter, novel IT strategies cannot transform the pharmaceutical industry the discovery, development, and delivery to the patient of innovative new medicines meeting a variety of unmet medical needs is entirely dependent on the successful implementation and integration of powerful, predictive, and pervasive computing. 

For pharmaceutical purposes, oue of the maiu problems will be to defiue the botanical origin of the different olibanum resins. Up to now, there are no scientifically current pharmaceutical monographs on olibanum, and pharmaceutical companies that want to develop new medicinal products have an urgent need of analytical methods for the botanical identihcation and quality assurance of the resins. Attempts had been made by Hahn-Deinstrop et al. [2]. 

The objective for Medicinal Chemistry is the identification of the chemical structures for potential new medicines. Eventually, these new medicines will be launched into the market to address unmet medical needs and to improve the quality of life for all human beings. The marketing of new medicines is the lifeblood of the pharmaceutical industry. Due to the broad impact Medicinal Chemistry has in the drug discovery process, it is recognized as a top job for synthetic organic chemists. 

The objective for Process Chemistry is to establish clean cost-effective manufacturing processes for new medicines identified by Medicinal Chemistry in a timely manner. At an absolute minimum, the reproducibility of the process and the quality of the final products has to meet established standards, such as the ICH guidelines. 

Pharmacogenomics Finding New Medicines Quicker and More Efficiently 1129... 

Develop medicines and therapies that can cure currently untreatable diseases. In spite of the great progress that has been made in the invention of new medicines by chemists, and new materials and delivery vehicles by engineers, the challenges in these directions are vast. New medicines to deal with cancer, viral diseases, and many other maladies will enormously improve human welfare. 

Building on the approach that allows optimization of biological systems through evolution, this would let a system produce the optimal new substance, and produce it as a single product rather than as a mixture from which the desired component must be isolated and identified. Self-optimizing systems would allow visionary chemical scientists to use this approach to make new medicines, catalysts, and other important chemical products—in part by combining new approaches to informatics with rapid experimental screening methods. 

Chemists are also interested in developing reactions that produce new asymmetric centers within molecules. There is significant interest in the development of new catalysts that produce centers of asymmetry, or handedness, within molecules that have no preferred handedness to start. Simple chiral molecules generated by these asymmetric catalysts are important building blocks for new medicines and research tools. 

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