Effect of the Similarity of Formulations and Excipients of Approved Generic Drug Products on In Vivo Bioequivalence for Putative Biopharmaceutics Classification System Class III Drugs

• Main Authors: Ping Ren (Author), Theresa Chan (Author), Wen-Cheng Yang (Author), Mitchell Frost (Author), Yan Wang (Author), Markham Luke (Author), Myong-Jin Kim (Author), Robert Lionberger (Author), Yi Zhang (Author)
• Format: Book
• Published: MDPI AG, 2023-09-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

One of the potential essential factors that restricts generic industry from applying the Biopharmaceutics Classification System (BCS) Class III biowaiver is adherence to the stringent formulation criteria for formulation qualitative (Q1) sameness and quantitative (Q2) similarity. The present study h...