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Specification of Drug Substances and Products
C M Riley
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Description for Specification of Drug Substances and Products
Hardcover. Presents a critical analysis of the requirements and approaches to setting specifications for the new pharmaceutical products, with an emphasis on phase-appropriate development and validation of analytical methods. This title offers a guide to industry practices of analytical methodologies used in the specification of drug substances and products. Num Pages: 390 pages, Illustrated. BIC Classification: MMG; TDCW. Category: (P) Professional & Vocational. Dimension: 243 x 192 x 21. Weight in Grams: 970.
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.
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.
Product Details
Publisher
Elsevier Science & Technology United Kingdom
Number of pages
390
Format
Hardback
Publication date
2013
Condition
New
Weight
970g
Number of Pages
390
Place of Publication
London, United Kingdom
ISBN
9780080983509
SKU
V9780080983509
Shipping Time
Usually ships in 4 to 8 working days
Ref
99-1
About C M Riley
Dr. Christopher Riley is the President of Riley and Rabel Consulting Services. He received a bachelor’s degree in Pharmacy (1977) and PhD degree in Pharmaceutical Chemistry (1980) from the University of Bath, UK. He taught Pharmaceutical Chemistry, at the Universities of Florida (1983-6) and the University of Kansas (1986-94), and was a Vice President at DuPont Merck (1994-2001) and ALZA ... Read more
Reviews for Specification of Drug Substances and Products
"...a valuable addition to a pharmaceutical scientists’ library….relevant and of interest to various “stake-holders in the drug development arena, including chemists, analysts, and programme managers. I can recommend it."
Organic Process Research & Development Journal, Sep-14 "Its main role is to explain how to meet the most recent International Conference on Harmonization guidelines for drug development. The book ... Read more
Organic Process Research & Development Journal, Sep-14 "Its main role is to explain how to meet the most recent International Conference on Harmonization guidelines for drug development. The book ... Read more