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Get Active Pharmaceutical Ingredients. Development, PDF

By Stanley Nusim

ISBN-10: 082470293X

ISBN-13: 9780824702939

This advisor bargains present and well timed discussions of the method improvement cycle, layout engineering, the approval method, qc and coverage, and validation, in addition to plant production actions together with fabrics administration, upkeep, and defense.

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Extra resources for Active Pharmaceutical Ingredients. Development, Manufacturing, and Regulation

Example text

The principal process development milestones are shown. timely to present the full spectrum of the bulk drug development disciplines and all the activities that they carry out, including those shared with others in the corporation or with outsources, as shown in Fig. 12. 3. The Consolidation Stage Although it is not infrequent for a significant bulk process ‘‘loose end’’ to remain tenaciously loose until late in the cycle, by and large the development cycle reaches a stage at which the more difficult development work has been done.

Process Development 27 Figure 8 The scope of the preparative task. Some examples to illustrate the dependence of the preparative effort on drug potency, therapeutic target, and scope of the clinical effort. Fig. 8 complements the range of preparative scopes presented in Table 1. Also depending on the resources of the organization, synthesis bench work may take place in search of routes that can support a manufacturing process, as the routes used during the discovery phase are largely unsuitable on the basis of projected cost, length of the synthesis cycle, commercial unavailability of starting materials or simply because of their perceived inferiority relative to what the process chemists foresee as attractive alternatives.

Although the biobatch and preapproval inspection prerequisites are specific to USFDA approvals, analogous expectations are arising in other drug agencies in the major markets (more on this in Chapter 3). The biobatch is a distinct marker in dosage form development in that it serves as the bioavailability=bioequivalence bridge to pivotal clinical studies, as well as the bioavailability=bioequivalence reference for all subsequent dosage form output. As such, the biobatch reflects the Process Development 23 process that goes into the dossier, uses representative bulk drug and excipients, and its size is no less than 10% of the intended manufacturing scale.

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Active Pharmaceutical Ingredients. Development, Manufacturing, and Regulation by Stanley Nusim


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