Chapter 12. Pharmaceutical and Biopharmaceutical Drug Manufacturing

  1. J. Rick Turner

Published Online: 1 MAR 2007

DOI: 10.1002/9780470174340.ch12

New Drug Development: Design, Methodology, and Analysis

New Drug Development: Design, Methodology, and Analysis

How to Cite

Turner, J. R. (2007) Pharmaceutical and Biopharmaceutical Drug Manufacturing, in New Drug Development: Design, Methodology, and Analysis, John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9780470174340.ch12

Author Information

  1. Department of Clinical Research, Campbell University School of Pharmacy, Morrisville, North Carolina

Publication History

  1. Published Online: 1 MAR 2007
  2. Published Print: 11 JUL 2007

ISBN Information

Print ISBN: 9780470073735

Online ISBN: 9780470174340

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Keywords:

  • clinical development;
  • drug product blinding;
  • quality control;
  • protein biopharmaceuticals;
  • immediate release

Summary

This chapter contains sections titled:

  • Introduction

  • Nonclinical Development

  • Drug Products for Clinical Trials

  • Commercial Manufacturing

  • Quality Control: Building Quality into the Process

  • Stability Studies

  • Immediate Release and Modified Release Tablets and Capsules

  • Producing Recombinant Protein Biopharmaceuticals