Drug development strategy

Tukker, G., Houston, J. B., Huang, S.-M., Optimizing drug development strategies to assess drug metabolism/ transporter interaction potential — toward a consensus, Clin. Pharmacol. Ther. 2001, 70, 103-114. 

The use of BRMs to treat human disease has its origins in the use of bacterial toxins to treat cancer by William B. Coley.73 These early studies resulted in the use of microbi-ally-derived substances such as BCG, Picibanil, carbohydrates from plants or fungi such as Krestin and Lentinan, other products such as Biostim and Broncho-Vaxom, as well as thymic extracts (Table 9.4). However, the lot-to-lot variation in the manufacture of these drugs has dampened enthusiasm. Equally, the focus on MOAs in drug development strategies has also dampened developmental efforts. The particulate nature of some BRMs can also result in pulmonary thrombosis and respiratory distress following i.v. injection. However, BRMs are commonly used to treat bladder cancer and derivatives of natural products are routinely used clinically. 

Figure 11.2 Challenges facing the pharmaceutical companies. (Source Adapted from Belsey, MJ. Drug developer strategies to boost competitiveness, Nature Reviews Drug Discovery, 6 265-266 (2007).)...

The GPC spin column/ESI-MS method has been applied to a number of RNA problems of pharmaceutical interest as an expedient and sensitive method in drug development strategies involving RNA-metabolizing enzymes [23], These include (i) the profiling of drug candidates to identify ones that do not bind to... 

Tucker GT, Houston BJ, Huang S-M. Optimising drug development strategies to assess... 

Dykens, J.A. (2007) RedOx Targets Enzyme Systems and Drug Development Strategies for Mitochondrial Dysfrmction, in Comprehensive Medicinal Chemistry II (eds D.J. Triggle and J.B. Taylor), Elsevier, Oxford, pp. 1053-1087. 

GuedJ, Ilan, and David Scharfstein. 2004. Organizational Scope and Investment Evidence from the Drug Development Strategies of Biopharmaceutical Firms. National Bureau of Economic Research Working Paper. 

Million RP. Impaet of genetie diagnosties on drug development strategy. Nat Rev Drug Discov 2006 5 459 62. 

Tucker T, Houston JB, Huang S-M. Optimizing drug development strategies to assess drug metabolism/transporter interaction potential—toward a consensus. Clin Pharmacol Ther 2001 70, 103 Br J Clin Pharmacol 2001 52, 107 Eur J Pharm Sci 2001 13, 417 Pharm Res 2001 18, 1071. 

Manasco PK, Arledge TE. Drug development strategies. In Rothstein MA, ed. Pharmacogenomics Social, Ethical, and Clinical Dimensions. Hoboken, NJ Wiley, 2003 83-97. 

Since the protein target and the chemical modulator are unknown, for this drug development strategy methodologies are required that lead to structurally complex and diverse small molecules covering a broad region of the so-called chemical space [2, 6]. This is one of the main focuses of diversity-oriented... 

In practice, however, the outcome was quite unexpected. In 1994, the year the Memorandum was implemented, the SCD received only 55 American dossiers, which is almost 50 percent less that the previous year s total of 103 dossiers. At the same time, the drug development strategy of the largest American pharmaceutical companies (MSD, BMS, Eli Lilly, Upjohn, Pfizer, etc.) in Russia has not changed dramatically. Moreover, it is at that time that these companies turned to larger multicenter projects as well as postmarketing research in Russia. 

Ranking of compounds in research by mode of action are shown in the second column of Table 43.11. Discussion of these mechanisms appears elsewhere in this book, but it is worth noting that the list is headed by two anticancer drug development strategies whose validity has yet to be established. 

Steele, V.E. et al.. Cancer chemoprevention drug development strategies for resveratrol, Pharm. Biol, 36,1,1998. 

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