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Quantitative methods and modeling to assess COVID‐19‐interrupted in vivo pharmacokinetic bioequivalence studies with two reference batches

The coronavirus disease 2019 (COVID‐19) has presented unprecedented challenges to the generic drug development, including interruptions in bioequivalence (BE) studies. Per guidance published by the US Food and Drug Administration (FDA) during the COVID‐19 public health emergency, any protocol change...

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Detalles Bibliográficos
Autores principales:	Gong, Yuqing, Feng, Kairui, Zhang, Peijue, Lee, Jieon, Pan, Yuzhuo, Zhang, Zhen, Ni, Zhanglin, Bai, Tao, Yoon, Miyoung, Li, Bing, Kim, Carol Y., Fang, Lanyan, Zhao, Liang
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	John Wiley and Sons Inc. 2022
Materias:	Research
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9111087/ https://www.ncbi.nlm.nih.gov/pubmed/35411692 http://dx.doi.org/10.1002/psp4.12795

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