Active Pharmaceutical Ingredients
eBook - PDF

Active Pharmaceutical Ingredients

Development, Manufacturing, and Regulation, Second Edition

  1. 456 pages
  2. English
  3. PDF
  4. Available on iOS & Android
eBook - PDF

Active Pharmaceutical Ingredients

Development, Manufacturing, and Regulation, Second Edition

About this book

To successfully bring an Active Pharmaceutical Ingredient (API) to market, many steps must be followed to ensure compliance with governmental regulations. Active Pharmaceutical Ingredients is an unparalleled guide to the development, manufacturing, and regulation of the preparation and use of APIs globally. Topics include: Safety, efficacy, and envi

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Yes, you can access Active Pharmaceutical Ingredients by Stanley Nusim in PDF and/or ePUB format, as well as other popular books in Medicine & Pharmacology. We have over one million books available in our catalogue for you to explore.

Information

Publisher
CRC Press
Year
2016
Print ISBN
9781439803363
eBook ISBN
9781439803394
Edition
2
Subtopic
Pharmacology

Table of contents

  1. Front Cover
  2. Preface
  3. Contents
  4. Contributors
  5. 1. Introduction
  6. 2. Bulk Drugs: The Process Development Task
  7. 3. Bulk Drugs: Process Design, Technology Transfer, and First Manufacture
  8. 4. Design and Construction of API Manufacturing Facilities
  9. 5. Regulatory Affairs: Requirements and Expectations
  10. 6. Regulatory Affairs: Guidelines, Evolving Strategies, and Issues
  11. 7. Validation of Active Pharmaceutical Ingredients
  12. 8. Quality of Active PHarmaceutical Ingredients
  13. 9. Environmental Control
  14. 10. Thermochemical Process Safety - An Introduction
  15. 11. Design and Operating Practices for Safety
  16. 12. Plant Operations
  17. 13. Sterile Bulk Active Pharmaceutical Ingredient Production
  18. 14. Biological Production of Active Pharmaceutical Intermediates
  19. 15. Supply Management
  20. 16. Equipment Maintenance and Reliability
  21. Index
  22. Back Cover