Specification Of Drug Substances And Products: Development And Validation Of Analytical Methods

Paperback | October 30, 2017

byChristopher M. Riley, Thomas W. Rosanske, Shelley R. Rabel Riley

not yet rated|write a review
Specification of Drug Substances and Products: Development and Validation of Analytical Methods is a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development and validation of analytical methods. This book is intended as more than a review of new regional guidelines, existing regulatory guidance, and industry practices. It provides a hands-on guide to understanding and applying these in practice. The authors discuss critical issues, novel approaches, and future directions while also providing insight into how International Guidelines were developed and the rationale behind them. Guide to industry best practices of analytical methodologies used in the specification of new drug substances and products e.g. DOE, QbD Critical assessment of the application of ICH guidelines on method validation and specification setting, written by experts involved in the development and application of the guidelines to aid understanding of requirements and what is expected by regulatory authorities Direct applicability to the day-to-day activities in drug development and the potential to increase productivity

Pricing and Purchase Info

$159.50 online
$171.95 list price (save 7%)
Pre-order online
Ships free on orders over $25

From the Publisher

Specification of Drug Substances and Products: Development and Validation of Analytical Methods is a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development and validation of analytical methods. This book is inten...

From the Jacket

Specification of Drug Substances and Products: Development and Validation of Analytical Methodsis a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development and validation of analytical methods. This book is intend...

President of Riley and Rabel Consulting Services. Former Vice President of Analytical R&D at DuPont Pharmaceutical Company, and Vice President of ChemPharm at ALZA (a division of Johnson and Johnson) as well as a member of the ICH Expert Working Group on Impurities.Director of Business Development at Acceleration Laboratory Services, I...

other books by Christopher M. Riley

The Hollywood Standard: The Complete and Authoritative Guide to Script Format and Style
The Hollywood Standard: The Complete and Authoritative ...

Paperback|Aug 1 2009

$25.40 online$32.50list price(save 21%)
Nasa Voyager 1 & 2 Owners' Workshop Manual - 1977 Onwards (vgr77-1 To Vgr77-3, Including Pioneer 10…
Nasa Voyager 1 & 2 Owners' Workshop Manual - 1977 Onwar...

Hardcover|Aug 25 2015

$40.66 online$43.95list price(save 7%)
NASA Apollo 11: An Insight into the Hardware from the First Manned Mission to Land on the Moon
NASA Apollo 11: An Insight into the Hardware from the F...

Hardcover|Jan 1 2010

$41.23 online$43.95list price(save 6%)
see all books by Christopher M. Riley
Format:PaperbackDimensions:390 pages, 8.75 × 6.35 × 0.68 inPublished:October 30, 2017Publisher:Elsevier Science & TechLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:0081013132

ISBN - 13:9780081013137

Look for similar items by category:

Customer Reviews of Specification Of Drug Substances And Products: Development And Validation Of Analytical Methods

Reviews

Extra Content

Table of Contents

Part One: Basic Concepts and Definitions

  1. Introduction
  2. General Principles and Regulatory Considerations: Specifications
  3. Application of Quality by Design (QbD) to the Development and Validation of Analytical Methods
  4. General Principles and Regulatory Considerations: Method Validation
  5. Part Two: Universal Tests

  6. Description and Identification
  7. Assay, and Impurities
  8. Residual Solvents
  9. Inorganic Impurities (Heavy Metals)
  10. Part Three: Specific Tests: Drug Substances

  11. Solid-State Characterization
  12. Chiral Methods
  13. Water Determination
  14. Part Four: Specific Tests: Drug Products

  15. Dissolution and Disintegration
  16. Extractables and Leachables
  17. Potency Assays for Biomolecules
  18. Host Cell Protein Assays
  19. Part Five: Pharmacopeial Methods

  20. Pharmacopeial Methods and Tests
  21. Part Six: Microbial Methods

  22. Sterile and Non-Sterile Products
  23. Part Seven: Biological Fluids

  24. Biological Fluids