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Tags: Validation methods

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Peer-reviewed journal (1-1 of 1)

  1. Investigation of Preprocessing and Validation Methodologies for PAT: Case study of the granulation and coating steps for the manufacturing of ethenzamide tablets

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    09 Jun 2023 | Contributor(s):: Shibayama, Shojiro, Funatsu, Kimito

    After the Food and Drug Association in the USA published guidelines on the enhanced use of process analytical technology (PAT) and continuous manufacturing, many studies regarding PAT and continuous manufacturing have been published. This paper describes a case study involving granulation and...