Opinion - (2025) Volume 9, Issue 2
Received: 03-Mar-2025, Manuscript No. fsb-25-171971;
Editor assigned: 05-Mar-2025, Pre QC No. P-171971;
Reviewed: 19-Mar-2025, QC No. fsb-25-171971;
Revised: 24-Mar-2025, Manuscript No. R-171971;
Published:
31-Mar-2025
, DOI: 10.37421/2577-0543.2025.9.218
Citation: Park, Hye Jin. ”IVIVC: Core to Drug Development and Biopredictio.” J Formul Sci Bioavailab 09 (2025):218.
Copyright: © 2025 Park J. Hye This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution and reproduction in any medium, provided the original author and source are credited.
This article offers a deep dive into the current hurdles and future directions for establishing In Vitro-In Vivo Correlation (IVIVC) and biopredictive dissolution methods. It highlights how these tools are crucial for drug development and regulatory decision-making, emphasizing the need for robust methodologies to bridge the gap between lab-based tests and actual drug performance in the body [1].
Here's a stepwise review focusing on the development of IVIVC models specifically for extended-release drug products. It systematically breaks down the process, offering a clear guide for researchers and developers to ensure predictable drug release and absorption over time, which is fundamental for patient compliance and therapeutic efficacy [2].
This article explores novel approaches to establishing IVIVC for topically applied drug products, a challenging area due to the complexities of skin penetration and localized drug action. It proposes new methodologies to better predict how topical formulations will perform in vivo based on in vitro data, aiming to streamline development for dermatological and transdermal medicines [3].
What this article really means is a look at the application of IVIVC within regulatory affairs, presenting it as a fresh perspective or 'new paradigm.' It emphasizes how regulatory bodies are increasingly leveraging IVIVC models to reduce the need for extensive clinical trials, leading to faster drug approvals and more efficient post-approval changes, benefitting both industry and patients [4].
This paper delves into the strategies for establishing IVIVC specifically for modified-release oral dosage forms. It outlines various approaches, from simple one-point correlations to complex multiple-point models, all designed to predict the in vivo performance of these complex formulations from their dissolution profiles, ensuring consistent therapeutic effects [5].
Here's the thing about amorphous solid dispersions: establishing IVIVC for them comes with unique challenges, but also significant opportunities. This article dissects these complexities, providing insights into how to overcome issues like stability and dissolution variability to achieve reliable predictions of in vivo performance, which is vital for new drug formulations [6].
This study focuses on using IVIVC to predict human pharmacokinetics, particularly concerning drug-drug interactions with CYP1A2 and CYP3A4 inhibitors. It demonstrates how in vitro enzyme inhibition data can be successfully correlated with in vivo outcomes, offering a way to forecast potential interactions and ensure drug safety earlier in development [7].
This systematic review gives us a comprehensive overview of IVIVC for lipid-based drug delivery systems. It synthesizes existing research, highlighting both the successes and challenges in correlating the in vitro performance of these complex formulations with their in vivo behavior, which is crucial for improving bioavailability of poorly soluble drugs [8].
Let's break down the advancements in IVIVC modeling, specifically for extended-release formulations. This review outlines how modeling techniques have evolved, offering more sophisticated ways to predict the performance of these drug products. It underscores the importance of predictive models in reducing development time and costs [9].
This article provides a comprehensive review of applying IVIVC to predict oral absorption. It covers various aspects, from theoretical frameworks to practical applications, demonstrating how IVIVC models are invaluable for forecasting how drugs will be absorbed after oral administration, ultimately guiding formulation optimization and biowaiver strategies [10].
In Vitro-In Vivo Correlation (IVIVC) stands as a critical concept in pharmaceutical science, essential for drug development and regulatory decision-making. It aims to establish a predictive relationship between an in vitro property of a dosage form, usually dissolution or release rate, and a relevant in vivo response, such as plasma drug concentration or amount of drug absorbed. What this really means is bridging the gap between controlled laboratory tests and how a drug actually performs in the human body. Current research extensively reviews the hurdles and future directions for establishing robust IVIVC and biopredictive dissolution methods, emphasizing their role in accelerating drug development and ensuring patient safety [1].
A significant portion of IVIVC applications focuses on complex drug delivery systems. For extended-release drug products, there's a systematic process involved in developing IVIVC models. This stepwise approach helps researchers ensure predictable drug release and absorption over time, which is fundamental for patient compliance and therapeutic efficacy [2]. Advancements in IVIVC modeling for these extended-release formulations have evolved, offering sophisticated ways to predict drug performance, ultimately reducing development time and costs [9]. Similarly, for modified-release oral dosage forms, strategies for establishing IVIVC outline various approaches, from simple correlations to complex multiple-point models, all designed to predict in vivo performance from dissolution profiles and ensure consistent therapeutic effects [5].
IVIVC is also being applied to more specialized and challenging drug types. For topically applied drug products, exploring new approaches to establish IVIVC is a demanding area due to the complexities of skin penetration and localized drug action. New methodologies are proposed to better predict how topical formulations will perform in vivo based on in vitro data, aiming to streamline development for dermatological and transdermal medicines [3]. Here's the thing about amorphous solid dispersions: establishing IVIVC for them comes with unique challenges, yet also significant opportunities. Research dissects these complexities, providing insights into overcoming issues like stability and dissolution variability to achieve reliable predictions of in vivo performance, which is vital for new drug formulations [6]. Moreover, a systematic review provides a comprehensive overview of IVIVC for lipid-based drug delivery systems, highlighting successes and challenges in correlating in vitro performance with in vivo behavior, crucial for improving the bioavailability of poorly soluble drugs [8].
The application of IVIVC extends significantly into regulatory affairs, presenting a new paradigm. What this article really means is how regulatory bodies are increasingly leveraging IVIVC models to reduce the need for extensive clinical trials, leading to faster drug approvals and more efficient post-approval changes, benefitting both industry and patients [4]. Furthermore, IVIVC proves invaluable in predicting human pharmacokinetics, particularly concerning drug-drug interactions with CYP1A2 and CYP3A4 inhibitors. This demonstrates how in vitro enzyme inhibition data can be successfully correlated with in vivo outcomes, offering a way to forecast potential interactions and ensure drug safety earlier in development [7]. A comprehensive review also highlights IVIVC's application in predicting oral absorption, covering theoretical frameworks and practical applications. It demonstrates how these models are invaluable for forecasting drug absorption after oral administration, ultimately guiding formulation optimization and biowaiver strategies [10].
The field of In Vitro-In Vivo Correlation (IVIVC) is pivotal in modern drug development and regulatory processes, aiming to bridge the gap between laboratory tests and actual drug performance within the body. Researchers are actively addressing challenges and exploring future directions for establishing robust IVIVC and biopredictive dissolution methods, recognizing their crucial role in regulatory decision-making and ensuring predictable drug behavior. A significant focus is on developing IVIVC models for various complex drug products. For instance, there's specific work on extended-release drug products, providing stepwise reviews to guide predictable drug release and absorption, which is key for patient compliance. Advancements in modeling techniques further enhance the predictability of these formulations, leading to reduced development time and costs. Modified-release oral dosage forms also see strategic development of IVIVC, using various correlation models to ensure consistent therapeutic effects based on dissolution profiles. The application of IVIVC extends to challenging areas like topically applied drug products, where novel methodologies are being explored to predict in vivo performance from in vitro data. Moreover, complex formulations like amorphous solid dispersions present unique challenges and opportunities for establishing IVIVC, with ongoing efforts to overcome stability and dissolution variability. Lipid-based drug delivery systems are also under systematic review to correlate their in vitro performance with in vivo behavior, particularly for improving the bioavailability of poorly soluble drugs. Beyond formulation-specific applications, IVIVC is increasingly applied in regulatory affairs as a new paradigm to streamline drug approvals and post-approval changes by reducing the need for extensive clinical trials. It also plays a role in predicting human pharmacokinetics, especially concerning drug-drug interactions involving enzymes like CYP1A2 and CYP3A4, offering a way to forecast potential interactions and ensure drug safety. A comprehensive review highlights the invaluable role of IVIVC in predicting oral absorption, guiding formulation optimization and biowaiver strategies. This collective body of research underscores IVIVC's broad impact across drug design, development, safety, and regulatory pathways.
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Journal of Formulation Science & Bioavailability received 23 citations as per Google Scholar report
