Transcription of Chapter-2 Analytical Method Development and …
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Chapter-2 Analytical Method Development and …
Chapter-2 . Analytical Method Development and Validation Overview The primary focus of this chapter is on general approaches and considerations toward Development of chromatographic methods for separation, identification, and quantification of pharmaceutical compounds, which may be applied within the various functions in the drug Development continuum. The chapter also discusses the issues and parameters that must be considered in the validation of Analytical methods . At the end of the chapter , a scope of the present research study is covered. GENERAL INTRODUCTION. The number of drugs introduced into the market is increasing every year. These drugs may be either new entities or partial structural modification of the existing one. Very often there is a time lag from the date of introduction of a drug into the market to the date of its inclusion in pharmacopoeias.
Chapter-2 57 Method validation The need to validate an analytical or bioanalytical method is encountered by analysis in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a
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