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

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Örtmek 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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Biçim PDF ● Sayfalar 96 ● ISBN 9781482229776 ● Editör Michael E. Swartz ● Yayımcı CRC Press ● Yayınlanan 2018 ● İndirilebilir 3 kez ● Döviz EUR ● Kimlik 6738219 ● Kopya koruma 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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