Pharmaceutical industry drug development

Regulatory and legal aspects of drug development, 27. Industry Profile, Pharmaceutical Research and Manufacturers of America, Washington, DC, 2000, pp. 22-47. 

These two considerations have not declined in importance with time. As medicines inexorably climb in price over the rate of inflation and less westernized countries develop pharmaceutical industries, admittedly small compared to the financial magnitude of major western companies, western governments are caught between two conflicting interests. The interest of the citizen who cannot access the medicines they need and the western pharmaceutical companies fear that competition will prevent annual record profits. To relinquish the pharmaceutical product patent will reduce barriers to market entry, facilitating competition and leading to lower drug prices at home and abroad. 

JUERGEN SIEPMANN is Professor of Pharmaceutical Technology, Universite Lille Nord de France, Lille, France. He received his Ph.D. from the Freie Universitaet Berlin, Berlin, Germany, in 1999. Since 2006, Dr. Siepmann has been Head of Controlled Drug Delivery Systems Mechanisms and Optimization, a research group. He is also Reviews Editor of the International journal of Pharmaceutics and is on the editorial boards of the journal of Controlled Release, the European journal of Pharmaceutics and Biopharmaceutics, the European journal of Pharmaceutical Sciences, and Drug Development and Industrial Pharmacy, among others. 

Quinine Actinometry as a method for calibrating ultraviolet radiation intensity in light-stability testing of pharmaceuticals. Yoshioka S. et al., Drug Development cmd Industrial Pharmacy, 20 (13), 2049-2062(1994). 

Ganem-Quintanar, A. Quintanar-Guerrero, D. Buri, P. Monoolein a review of the pharmaceutical applications. Drug Development and Industrial Pharmacy, 2000, v. 26 (8), 809-820. 

G.W. Skinner, W.W. Harcum, RE. Barnum, J.-H. Guo, The evaluation of fine-particle hydroxypropylcellulose as a roller compaction binder in pharmaceutical applications. Drug Development and Industrial Pharmacy, 25,1121-1128,1999. 

D.S.T. Hsieh, Subcutaneous controlled dehvery of estradiol by compudose implants In vitro and in vivo evaluations. Drug Development and Industrial Pharmaceutics, 13,2651-2666,1987. 

Alexander, K.S., Azizi, J., Dollimore, D., and Patel, FA., 1989, An Interpretation of the Sedimentation Behavior of Pharmaceutical Kaolin and other Kaolin Preparations in Aqueous Environments , Drug Development and Industrial Pharmacy, 15(14016), pp 2559-2582. 

Khalil, S.A.H., and El-Masry, S., 1974, Adsorption of Atropine and Hyoscine on Magnesium Tiisihcate , Journal of Pharmaceutics and Pharmacology, 26, pp 243-248. Khahl, S.A.H., Mortada, L.M., Shams-Eldeen,M.A., and El-Khawas,M.M., 1987, The in vitro Uptake of a Low Dose Drur (Riboflavine) by Some Adsorbents , Drug Development and Industrial Pharmacy, 13(3), pp 547-563. 

It was apparent that the FDA recognized the ability of the pharmaceutical industry to develop chiral assays. With the advent of chiral stationary phases (CSPs) in the early 1980s [8, 9], the tools required to resolve enantiomers were entrenched, thus enabling the researcher the ability to quantify, characterize, and identify stereoisomers. Given these tools, the researcher can assess the pharmacology or toxicology and pharmacokinetic properties of enantiopure drugs for potential interconversion, absorption, distribution, and excretion of the individual enantiomers. 

Due to FDA policies, this was a pivotal point for the pharmaceutical industry and established the onslaught of mergers for the development of enantiopure drugs. 

As markets for enantiopure drugs continue to develop, the pharmaceutical industry, fine chemical companies, and academic chemists are prospecting for new enan-tioselective technologies to produce them. 

The Japanese regulatory authority is the Ministry of Health and Welfare (MHW) and the Pharmaceutical and Medical Safety Bureau (PSMB) is responsible for the promulgation of national and international guidelines in the form of Notifications. Guidelines are available on the Internet web-site of the National Institute of Health and Science (http //www.nihs.go.jp). The MHW has not issued specific guidance on the development of chiral drugs, but has nonetheless responded to the enantiomer-versus-racemate scientific debate. The attitude of the MHW and its advisory body, the Central Pharmaceutical Affairs Council (CPAC) is discussed in two articles by Shindo and Caldwell published in 1991 and 1995 [17, 18]. The latter paper analyzes the results of a survey of the Japanese pharmaceutical industry which sought responses on chirality issues. 

Combinatorial chemistry, a new chapter of organic synthesis, is now developing rapidly. This new approach to synthesizing large designed or random chemical libraries through application of solid phase synthetic methods, promises to revolutionize the process of drug discovery in the pharmaceutical industry.24... 

As the twentieth century came to a close, the job market for computational chemists had recovered from the 1992-1994 debacle. In fact, demand for computational chemists leaped to new highs each year in the second half of the 1990s [135]. Most of the new jobs were in industry, and most of these industrial jobs were at pharmaceutical or biopharmaceutical companies. As we noted at the beginning of this chapter, in 1960 there were essentially no computational chemists in industry. But 40 years later, perhaps well over half of all computational chemists were working in pharmaceutical laboratories. The outlook for computational chemistry is therefore very much linked to the health of the pharmaceutical industry itself. Forces that adversely affect pharmaceutical companies will have a negative effect on the scientists who work there as well as at auxiliary companies such as software vendors that develop programs and databases for use in drug discovery and development. 

The new major challenge that the pharmaceutical industry is facing in the discovery and development of new drugs is to reduce costs and time needed from discovery to market, while at the same time raising standards of quality. If the pharmaceutical industry cannot find a solution to reduce both costs and time, then its whole business model will be jeopardized The market will hardly be able, even in the near future, to afford excessively expensive drugs, regardless of their quality. 

Anyone who has worked for some time in the pharmaceutical industry has a story of how a successful drug was developed after a fortuitous coffee machine encounter between two or more scientists, or how a problem was not discovered until late-stage development because an important piece of information was missed. 

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