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

• मुख्य लेखकों: Ping Ren (लेखक), Theresa Chan (लेखक), Wen-Cheng Yang (लेखक), Mitchell Frost (लेखक), Yan Wang (लेखक), Markham Luke (लेखक), Myong-Jin Kim (लेखक), Robert Lionberger (लेखक), Yi Zhang (लेखक)
• स्वरूप: पुस्तक
• प्रकाशित: MDPI AG, 2023-09-01T00:00:00Z.
• विषय: article
• ऑनलाइन पहुंच: 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...