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- W595560439 abstract "Introduction to FDA pre-NDA approval inspections developing a strategic approach to preparing for a succesful pre-NDA approval inspection international perspectives of a preapproval inspection stability data and pre-approval inspections successful management of a pre-approval inspection the validation of pharmaceutical processes preparaing for the pre-approval inspection through retrospective documentation technology transfer and scale-up training of personnel in the pharmaceuticalindustry compliance with cGMP and application commitments." @default.
- W595560439 created "2016-06-24" @default.
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- W595560439 date "1998-10-15" @default.
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- W595560439 title "Preparing for FDA Pre-Approval Inspections" @default.
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