Download e-book for iPad: Active Pharmaceutical Ingredients: Development, by Stanley Nusim

By Stanley Nusim

Targeting the 3 most important elements that effectively convey an API to market-process improvement, production, and governmental rules and approval-this reference serves as a step by step consultant to the making plans and transparent realizing of the majority production of APIs. This consultant bargains present and well timed discussions of the method improvement cycle, layout engineering, the approval method, qc and insurance, and validation, in addition to plant production actions together with fabrics administration, upkeep, and safeguard.

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Additional resources for Active Pharmaceutical Ingredients: Development, Manufacturing, and Regulation (Drugs and the Pharmaceutical Sciences)

Example text

Figure 10 Materials flow from the bulk drug preparative effort. The width of the arrows approximately indicates the relative amounts of bulk drug going to the users in the overall drug development program. Examination of this figure and Fig. 9 provides an equally approximate description of the bulk drug usage as a function of the development cycle. 30 Rosas 2. The Development Stage As made clear by the slope of the curve in the know-how vs. applied effort plane (Fig. 6), the development stage comprises the most productive development effort: (a) Synthesis work at the bench scale seeks the eventual manufacturing route in earnest, preferably on more than one approach, with all promising a substantial, if not overwhelming, advantage over the current preparative procedures.

2. , units to measure fouling rates of surfaces over short-term test, small-scale 46 Rosas centrifuges to more reliable measure centrifugation rates, leaf test units for vacuum filtration tests). It so happens that often enough studies and measurements cannot be made in processing equipment nearly as well as they can be made in a smaller-scale apparatus dedicated for the purpose at hand. The enterprising scale-up team will, in due course, assemble and accumulate such test apparatus as the needs arise.

Thus, the curve in Fig. 6 describes the accumulation of know-how during four distinct phases of the process development effort: a. The preparative stage, during which the effort is focused on making available kilogram amounts of the bulk drug to the preclinical, toxicology, and Phase I work, usually not based on the eventual synthesis route, let alone the eventual process. Whereas the synthesis route (or scheme) describes the intermediate chemical structures sought to arrive at the final compound (starting materials, synthesis approach, and probable chemical reactions to use), the process describes how the route is implemented at a much higher level of detail.

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Active Pharmaceutical Ingredients: Development, Manufacturing, and Regulation (Drugs and the Pharmaceutical Sciences) by Stanley Nusim


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