Specification of Drug Substances and Products

Development and Validation of Analytical Methods

Nonfiction, Science & Nature, Science, Biological Sciences, Biochemistry, Biotechnology, Health & Well Being, Medical
Cover of the book Specification of Drug Substances and Products by Elsevier Science, Elsevier Science
View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart
Author: Elsevier Science ISBN: 9780080983431
Publisher: Elsevier Science Publication: August 21, 2013
Imprint: Elsevier Language: English
Author: Elsevier Science
ISBN: 9780080983431
Publisher: Elsevier Science
Publication: August 21, 2013
Imprint: Elsevier
Language: English

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
View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart

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.

More books from Elsevier Science

Cover of the book Stimuli Responsive Polymeric Membranes by Elsevier Science
Cover of the book Russian Social Science Reader by Elsevier Science
Cover of the book Business Continuity and Disaster Recovery Planning for IT Professionals by Elsevier Science
Cover of the book Data Architecture: A Primer for the Data Scientist by Elsevier Science
Cover of the book Handbook of Magnetic Materials by Elsevier Science
Cover of the book Structured Parallel Programming by Elsevier Science
Cover of the book Diesel Engine System Design by Elsevier Science
Cover of the book Solid Oxide Fuel Cell Lifetime and Reliability by Elsevier Science
Cover of the book Brugada Phenocopy by Elsevier Science
Cover of the book Monitoring Water Quality by Elsevier Science
Cover of the book Diseases of the Small Intestine in Childhood by Elsevier Science
Cover of the book Vehicular Communications and Networks by Elsevier Science
Cover of the book Nonlinearity and Chaos in Molecular Vibrations by Elsevier Science
Cover of the book Molecular Biology of Placental Development and Disease by Elsevier Science
Cover of the book Nucleic Acid Sensing and Immunity - PART B by Elsevier Science
We use our own "cookies" and third party cookies to improve services and to see statistical information. By using this website, you agree to our Privacy Policy