Analytical Method Development and Validation

Häftad, Engelska, 1997

AvMichael E. Swartz,Ira S. Krull,USA) Swartz, Michael E. (Cambridge, Massachusetts,USA) Krull, Ira S. (Northeastern University, Boston, Massachusetts

939 kr

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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.

Produktinformation

Utgivningsdatum1997-05-16
Mått138 x 216 x 6 mm
Vikt180 g
FormatHäftad
SpråkEngelska
Antal sidor96
FörlagTaylor & Francis Inc
ISBN9780824701154

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Analytisk kemi inom Naturvetenskap och teknik

". . .a useful primer-type book covering validation of analytical methods. . . .recommended."---Analyst"Stop and read this. . .book to understand a formal way to develop or to improve and validate your methods. . .. In answer to any query posed to you about your methods development technique, you could hand your well-worn copy of this small book to the questioner. There should be no further questions."---INFORM