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Michael E. Swartz
Analytical Method Development and Validation [PDF ebook]

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غلاف Michael E. Swartz: Analytical Method Development and Validation (PDF)

Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.

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شكل PDF ● صفحات 96 ● ISBN 9781482229776 ● محرر Michael E. Swartz ● الناشر CRC Press ● نشرت 2018 ● للتحميل 3 مرات ● دقة EUR ● هوية شخصية 6738219 ● حماية النسخ Adobe DRM

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Ira S. Krull Michael E. Swartz Boston, Massachusetts, USA Northeastern University, Boston, Massachusetts, USA) Krull Ira S. (Northeastern University Massachusetts, USA) Swartz Michael E. (Synomics Pharmaceuticals Svcs LLC Boston, Massachusetts, USA) Krull Ira S. (Northeastern University

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