This work combines basic theory, current industrial practice and useful regulatory aspects in an overview of pharmaceutical stability. It examines data analysis of packaged drug's stability, experimental methods for achieving stable marketed products and the stability principles of drugs in dissolved, dispersed and solid states. This second edition: presents new information on the effect micro-environmental pH has on the stability and behaviour of solid-drug substances; discusses the advantages and limitations of harmonization; features updated coverage of computer programs for determining the stability function; and more.
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