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portada Specification of Drug Substances and Products: Development and Validation of Analytical Methods
Type
Physical Book
Publisher
Author
Year
2013
Language
English
Pages
390
Format
Hardcover
Dimensions
23.6x19.6x2 cm
Weight
0.98 kg.
ISBN13
9780080983509
Edition No.
1
Categories

Specification of Drug Substances and Products: Development and Validation of Analytical Methods

Riley, Christopher M. ; Rosanske, Thomas W. (Author) · Elsevier · Hardcover

Specification of Drug Substances and Products: Development and Validation of Analytical Methods - Riley, Christopher M. ; Rosanske, Thomas W.

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Delivery: 22 Oct - 29 Oct Shipping: 15 to 19 business days.
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Synopsis "Specification of Drug Substances and Products: Development and Validation of Analytical Methods"

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.

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