Best Practices for Microbial Challenge In-Use Studies to Evaluate the Microbial Growth Potential of Parenteral Biological Products; Industry and Regulatory Considerations
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DOI: 10.5731/pdajpst.2022.012806
文献链接: http://journal.pda.org/lookup/doi/10.5731/pdajpst.2022.012806
其他信息:
出版社: Parenteral Drug Association, Inc.
作者: Camellia Zamiri; Danielle L. Leiske; Patricia Hughes; J. Paul Kirwan; Evelyn Der; Emily Cox; Rob Warburton; Monica Goss; Sarah Weiser; Janet Perez-Brown; Ganapathy Gopalrathnam; Jing Liu; Shyam B. Mehta; Shebeer Shereefa; Sebastian Specht; Sandra J. Aedo; Pierre Goldbach; Feng Jia; Barbara Kuehnle; Scott Page; Liesbeth Voeten; Li Yi; Chen Zhu
