Pharmaceutical product development : insights into - download pdf or read online

By Vandana B. Patravale, John I. Disouza, Maharukh Rustomjee

Pharmaceutical product improvement is a multidisciplinary task related to broad efforts in systematic product improvement and optimization in compliance with regulatory gurus to make sure the standard, efficacy and safeguard of ensuing products.

Pharmaceutical Product improvement

equips the pharmaceutical formula scientist with vast and up to date wisdom of drug product improvement and covers all steps from the start of product belief to the ultimate packaged shape that enters the marketplace and lifecycle administration thereof.

Applications of middle medical rules for product improvement also are completely mentioned at the side of the newest ways related to layout of test and caliber by way of layout with accomplished illustrations according to useful case reviews of a number of dosage forms.

The ebook offers pharmaceutical product improvement info in an easy-to-read mode with simplified theories, case reports and guidance for college students, academicians and pros within the pharmaceutical undefined. it really is a useful source and hands-on advisor overlaying managerial, regulatory and useful features of pharmaceutical product lifecycle management.

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1 INTRODUCTION The prime objective of any pharmaceutical product design and development is to generate an assurance that the therapeutic active in the proposed formulation or dosage form is suitable, safe and effective for intended use and holds acceptable quality. The pharmaceutical industry, since its emergence, is expected to work with this vision while converting the market opportunity into commercial reality. Since it deals with human life, safety and health, regulations covering it are very stringent as they rightfully should be.

4 Primary PAT tools and their applications. , with respect to. Principal Concepts in Pharmaceutical Product Design and Development 27 For instance, consider a hypothetical example of a mixing unit operation performed for mixture ‘A’ using an octagonal blender wherein the desired quality target is a uniform blend, which can be analysed using near-infrared (NIR) spectroscopy. Here, the CPPs were identified to be loading volume, mixer speed and time of mixing based on initial studies. The optimised process revealed that uniform mixing can be achieved at a blender speed of 10 rpm for 10 min and the end point can be determined using NIR spectroscopy.

New York: Informa healthcare USA Inc. Hein, T. 2010. Product lifecycle management for the pharmaceutical industry. pdf (accessed June 19, 2015). ICH. 2005. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use, ICH harmonised tripartite guideline, quality risk management Q9. pdf (accessed June 19, 2015). , Komninos, N. 2015. Product life cycle management a guide to new product development. pdf (accessed June 19, 2015). PhRMA. 2015.

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