Developing validating dissolution procedures

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Validating the automated method is the primary challenge when transferring from the manual method.

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For early-phase products, minimal validation is required to screen the initial batches.As the pace of product development accelerates, the approach to dissolution-method development must advance beyond a manual method and an assay.A natural progression of the method-development process must include the transfer of the manual method onto automated instrumentation. This course has been entirely revised in order to reflect the content of the complete overhaul of USP General Chapter published in USP 38–NF 33 First Supplement with the official date of August 1, 2015.Building on your basic understanding of USP’s approach to dissolution, this course provides a foundation for developing and validating dissolution methods used for batch release and stability testing.

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