Pharmaceutical scientists, method development

Even though, there is no cookbook for HPLC method development this book provides several strategies that the reader could use when presented with a particular situation. These strategies could be stored as tools in the scientists method development arsenal, and drawn from when needed to tackle a particular separation. Moreover, some novel approaches for implementing HPLC, fast HPLC, and hyphenated HPLC techniques towards pharmaceutical analysis are discussed. This book has the potential to serve as a useful resource for the chromatographic community. It can be used as a handbook for the novice as well as the more experienced pharmaceutical chemist who utilizes HPLC as an analytical tool to solve challenging problems regularly in the pharmaceutical industry. 

A number of alternative sizing methods are available, and these are described in Table 8. The American Association of Pharmaceutical Scientists, Inhalation Focus Group conducted a comprehensive review of available methods, which was published in a series of articles identified in the last column of the table. All of the methods described either have been or are currently employed in the development of aerosol products. However, at this time only the inertial samplers, cascade impactors and impingers appear in compendial standards and in regulatory guidelines [44-46], Other methods such as thermal imaging are also under development and may give complementary size information to the current methods. 

A review of capillary electrophoresis applications in pharmaceutical analysis was published in 1993, and the goal of this chapter is to provide an update on the various disciplines within the technique and includes selected applications. Recent developments in the areas of capillary technology, instrumentation, and detection will be reviewed here. Useful strategies for method development involving several classes of pharmaceuticals and biotechnology products will be addressed. The formats within capillary electrophoresis have evolved to such an extent that this chapter is not comprehensive in scope. Therefore, the reader will be directed to other reviews on the various aspects of capillary electrophoresis. Of particular interest to many separation scientists may be a special issue of an Applied Biosystems Newsletter, which addresses the future role of CE, method development in CE, and selected applications in the area of drug analysis and protein separations [7]. 

Also, throughout this chapter we focus on analytical challenges a pharmaceutical scientist encounters during method development these include speed... 

Cocrystals are becoming increasingly important as a means of controlling the properties of pharmaceutical solids by designing multiple component molecular networks that introduce the desired functionality. Because cocrystal design is based on supramolecular synthesis, it provides a powerful approach for the proactive discovery of novel pharmaceutical solid phases. Application of the fundamental concepts presented here on cocrystallization processes is essential for the pharmaceutical scientist to anticipate the formation of cocrystals during pharmaceutical processes and storage, as well as to develop reliable methods for cocrystal discovery and production. 

Shaw, J.M. Sullivan, B.M. Bowen, W.E. Martin, G.P. Reed, R.A. Studies Directed Towards the Development of Enzymatic Dissolution Test Methods for Cross-Linked Hard Gelatin Capsule Formulations Containing Poorly Water-Soluble Drug Substances. Abstracts of the AAPS Annual Meeting, New Orleans, LA, Nov 14-18, 1999 American Association of Pharmaceutical Scientists Arlington, VA, 1999 Abstract No. 3358. 

Profile TPIMS is a nonprofit biomedical research institute focused on the development of combinatorial chemistry techniques that can be applied to all compound types. It was founded in 1988 to continue earlier research begun at The Scripps Research Institute in La Jolla, California, and in 1989 it began its research activities. Less than one year after beginning its operations, TPIMS scientists had developed a method for synthesizing and screening combinatorial libraries of tens of millions of peptides and other nonpeptide compounds. As a result of this early research, TPIMS became an internationally recognized research center in the field of molecular diversity and combinatorial chemistry. Research is funded by the National Institutes of Health, the National Science Foundation, the U.S. Army, and by a variety of pharmaceutical companies. 

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