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Quality Issues for Clinical Trial Materials Quality Issues for Clinical Trial Materials

Quality Issues for Clinical Trial Materials - PowerPoint Presentation

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Uploaded On 2018-11-21

Quality Issues for Clinical Trial Materials - PPT Presentation

The Chemistry Manufacturing and Controls CMC Review Dorota Matecka PhD Office of Pharmaceutical Quality OPQ CDER Outline Pharmaceutical Quality CMC Requirements for INDs CMC Safety Concerns ID: 731732

product drug clinical substance drug product substance clinical ind cmc quality information phase impurities products process safety investigational guidance

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