Pharmaceutical Development scientists

Traditionally, in pursuit of their structure-activity relationships, medicinal chemists had focused almost exclusively on finding compounds with greater and greater potency. However, these SARs often ended up with compounds that were unsuitable for development as pharmaceutical products. These compounds would be too insoluble in water, or were not orally bioavailable, or were eliminated too quickly or too slowly from mammalian bodies. Pharmacologists and pharmaceutical development scientists for years had tried to preach the need for medicinal chemists to also think about other factors that determined whether a compound could be a medicine. Table 1.1 lists a number of factors that determine whether a potent compound has what it takes to become a drug. Experimentally, it was difficult to quantitate these other factors. Often, the necessary manpower resources would not be allocated to a compound until it had already been selected for project team status. 

There are other considerations in searching for the most active API structure, creating the need for close collaboration with Pharmaceutical Development scientists. 

In this exciting perspective, the challenge we tried to take up was to combine reports of the latest academic research and comprehensive overviews of basic principles, with more applied contributions from the industry. The result is a unique book, ideal for pharmaceutical development scientists and researchers... 

Validation of aseptic pharmaceutical processes is specihcally assembled in the second edition as a reference for use by managers, supervisors, and scientists in the pharmaceutical industry. The primary intent of this work is to guide design engineers, manufacturing personnel, research and development scientists, and quality control professionals in validating those processes needed for nonaseptic and aseptic pharmaceutical production. 

For the pharmaceutical product development scientist, there is clearly a need for objective information about the practical performance of different excipients and their various grades. In this chapter we set out to bring together the results of some of our ongoing evaluations of the physical and mechanical properties of excipients commonly used for the manufacture of solid oral dosage forms. In this particular article, we have chosen to focus on the fillers that are most commonly used in the manufacture of immediate release tablets microcrystalline cellulose (MCC), lactose, calcium phosphate, and mannitol (1). 

The testing procedures used in this work have all been well described in the literature (4) and are focused on understanding the compression behavior of the powder samples and the mechanical properties of the resulting compacts. These methods are summarized in Table 1. For brevity, we have limited our initial studies to single component systems, but recognize that more work is needed in the future to understand the complex behavior of multicomponent mixtures. The current work should provide a sound basis for further work on such systems. It is intended that this treatise will enable pharmaceutical formulation scientists to better understand the similarities and differences between the most common grades and types of excipients, and will facilitate the rational selection of excipients for use in the development of immediate release tablet formulations. 

Finally, knowledge of excipient mechanical and physical properties is essential to creating a robust formulation that manufactures tablets that meet specifications in a time- and material-efficient manner. Excipient selection must also take into consideration API stability and biopharmaceutical performance of the dosage form. Uneducated selection of excipients will likely lead to numerous formulating iterations that require much time and material, which are luxuries that product development scientists do not have in the competitive pharmaceutical environment. 

As being part of a series launched under the umbrella of the IUBMB, the volume was planned to tackle not only the cutting edge research, but also to provide a source for basic, educational information. The target audience includes not only scientists and health professionals but also educators and students, policymakers, food and pharmaceutical developers, and many others interested in understanding how plant-derived phenolic compounds can affect human health and so, in part, explains how fruit and vegetables play a key role in enhancing human health. 

Combinatorial chemistry, a technique which quickly surveys huge numbers of chemical combinations in order to select the most desirable molecular configurations, attracts the attention of chemical companies. Scientists predict the possibility of creating numerous new chemicals to serve the needs of industrial and pharmaceutical development. 

Looking back over my 43 years working in the pharmaceutical industry, I can unequivocally say that Chou Tann was the best chemical process development scientist I ever had the privilege of working with. 

In many of Matsuda s works, there is reference to the principle of "action spectra," an important procedure used to determine the region of the spectra most responsible for photodegradation. He is the only pharmaceutical photostability scientist to apply this very important procedure to actual product development work (276,281,285,286). The apparatus he used for his studies is described in one of his papers on the photostability of ubidecarenone (284). 

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