Method validation in pharmaceutical analysis : a guide to best practice /
This second edition of a global best-seller has been completely redesigned and extensively rewritten to take into account the new Quality by Design (QbD) concept in pharmaceutical manufacturing. As in the first edition, the analytical requirements during the entire product lifecycle are covered, but...
| Other Authors: | , |
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| Format: | eBook |
| Language: | English |
| Published: |
Weinheim :
Wiley-VCH,
[2014]
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| Edition: | Second, completely revised and updated edition. |
| Subjects: | |
| Online Access: | Full Text via HEAL-Link |
| Summary: | This second edition of a global best-seller has been completely redesigned and extensively rewritten to take into account the new Quality by Design (QbD) concept in pharmaceutical manufacturing. As in the first edition, the analytical requirements during the entire product lifecycle are covered, but now a new section is included on continued performance monitoring and the transfer of analytical procedures. Two case studies from the pharmaceutical industry illustrate the concepts and guidelines presented, and the standards and regulations from the US (FDA), European (EMA) and global (ICH) regul. |
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| Physical Description: | 1 online resource. |
| Bibliography: | Includes bibliographical references and index. |
| ISBN: | 9783527672196 3527672192 9783527672202 3527672206 9783527335633 3527335633 |
| DOI: | 10.1002/9783527672202 |
