Chapter 10. New Products Manufacturing

  1. Dipak K. Sarker

Published Online: 24 DEC 2009

DOI: 10.1002/9780470773031.ch10

Quality Systems and Controls for Pharmaceuticals

Quality Systems and Controls for Pharmaceuticals

How to Cite

Sarker, D. K. (2008) New Products Manufacturing, in Quality Systems and Controls for Pharmaceuticals, John Wiley & Sons, Ltd, Chichester, UK. doi: 10.1002/9780470773031.ch10

Author Information

  1. School of Pharmacy and Biomolecular Sciences, University of Brighton, UK

Publication History

  1. Published Online: 24 DEC 2009
  2. Published Print: 15 AUG 2008

ISBN Information

Print ISBN: 9780470056929

Online ISBN: 9780470773031

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Keywords:

  • new products manufacturing;
  • medicines and pharmaceutical global regulators;
  • US Patent and Trademark Office (USPTO);
  • from inception to market place;
  • new drug application (NDA) and NEW drug chemical entity (NCE);
  • product life cycle showing sales versus time;
  • technology transfer circumventing developmental costs;
  • new product development - product design and specification

Summary

This chapter contains sections titled:

  • From inception to market place

  • New product development: product design and specification