CMC Considerations for a Successful Regulatory Submission Rapti D. Madurawe, Ph. D. Branch Chief Office of New Drug Quality Assessment 1 - Rapti - Document - PDFSEARCH.IO

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	CMC Considerations for a Successful Regulatory Submission Rapti D. Madurawe, Ph. D. Branch Chief Office of New Drug Quality Assessment 1 Add to Reading List Open Document File Size: 210,86 KB Share Result on Facebook IndustryTerm clinical test product / drug product / drug manufacturing process / / MedicalCondition diseases / / Organization D. Branch Chief office of New Drug Quality Assessment / FDA / / Product QTPP Example Pediatric Suspension / / ProvinceOrState Indiana / / SocialTag Health Pharmaceutical industry Food and Drug Administration Clinical research Drug safety Investigational New Drug Clinical trial Excipient Regulatory requirement Pharmacology

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