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

• Main Authors: Yuqing Gong (Author), Kairui Feng (Author), Peijue Zhang (Author), Jieon Lee (Author), Yuzhuo Pan (Author), Zhen Zhang (Author), Zhanglin Ni (Author), Tao Bai (Author), Miyoung Yoon (Author), Bing Li (Author), Carol Y. Kim (Author), Lanyan Fang (Author), Liang Zhao (Author)
• Format: Book
• Published: Wiley, 2022-07-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Abstract 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 protoc...