IVIVC for Modified Release dosage forms is a requirement of the USP. True False

Analysis of the Statement

1. Understanding IVIVC:

   • In Vitro-In Vivo Correlation (IVIVC) is a predictive relationship between an in vitro property of a dosage form and a relevant in vivo response. It is particularly important in the development and evaluation of modified-release dosage forms.

2. USP Requirements:

   • The United States Pharmacopeia (USP) sets standards for medicines, including guidelines for modified-release formulations. IVIVC is mandated in these guidelines to ensure the performance of modified-release dosage forms can be predicted based on laboratory testing, which enhances consistency and efficacy of the formulation.

Verification of the Statement

• Since IVIVC is indeed a requirement for modified-release dosage forms as per the guidelines set by USP, the statement provided is True.

Final Answer

True: IVIVC for Modified Release dosage forms is a requirement of the USP.