翻译：JULIA 来源：Julia法规翻译Elemental Impurities in Drug Products Guidance for Industry行业指南：药品中的元素杂质U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluationand Research (CBER) August 2018 Pharmaceutical Quality/CMC官网下载链接https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm509432.pdfThis guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the tit
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