Understanding Drug Behavior: In Vitro-In Vivo Correlation (IVIVC)
In Vitro-In Vivo Correlation (IVIVC) is a pivotal process in pharmaceutical development, bridging the gap between laboratory experiments (in vitro) and real-life clinical outcomes (in vivo). This correlation enables accurate predictions of drug behavior in humans based on in vitro data, providing invaluable insights for formulation optimization, dosage regimen determination, and regulatory compliance.
Overview
IVIVC establishes empirical and mechanistic connections between in vitro experiments and in vivo drug behavior, enabling pharmaceutical companies to predict drug performance in humans more accurately.
Why You Need In Vitro-In Vivo Correlation (IVIVC)
IVIVC is essential for pharmaceutical companies to ensure the efficacy, safety, and regulatory compliance of their drug formulations. By accurately predicting in vivo drug behavior based on in vitro data, companies can optimize formulations, dosing regimens, and clinical trial designs, ultimately expediting the drug development process.
Key Features
- Empirical and mechanistic correlations between in vitro and in vivo data.
- Accurate predictions of drug behavior in humans based on in vitro experiments.
- Optimization of drug formulations and dosing regimens.
- Enhanced regulatory compliance and accelerated drug development timelines.
Other Services
- Biopharm Design Input
- Biorelevant Specifications
- Pharmacokinetic/Pharmacodynamic
- PBPK Modelling/ PBBM Modelling
- Regulatory Query Response
- Regulatory & Medical Writing Nonclinical & Clinical Pharmacology of IND/IMPD and NDA Modules
- Statistical Analysis and Report submission to all major Regulatory Agencies
How it works
The IVIVC Process
In Vitro Characterization
Conduct comprehensive in vitro studies to characterize the drug formulation's properties, including dissolution behavior and drug release profiles.
Data Analysis
Analyze in vitro data to understand how the formulation behaves under different conditions and in various physiological environments.
Mathematical Modeling
Develop mathematical models to establish correlations between in vitro data and in vivo pharmacokinetic profiles.
Validation
Validate the IVIVC model using additional in vivo data to ensure its accuracy and reliability for predicting drug behavior in humans.
Years of Experience
Our vision is to empower health by envisioning a world where innovative medicines foster well-being and resilience, transforming lives.
Why Choose Us
In the realm of drug development, Biopharmetrics stands out for several reasons
In-House Bio-Pharm Expertise
We act as an in-house bio-pharm expert for the organizations and provide support to them at any time
Nimble Project Management
An expert bio-pharma consultant would be the SPOC for all the communications related to the project
Pharmacometric Modeling
Leveraging advanced modelling techniques, we quantify drug effects, predict outcomes, and optimize dosing regimens. This informs decision-making and enhances patient safety.
Patient-Centric Approach
We prioritize patient needs, ensuring that drug development aligns with real-world clinical practice. Patient perspectives guide our work.
Case Studies
Optimizing Preclinical PBPK Models for Human Application
Dive into our case study to discover how we refine preclinical PBPK models, bridging the gap between animal studies and human application for precise exposure predictions and dosage regimen optimization.
Oxcarbazepine ER Suspension: Development of In Vitro Dissolution Profile
Explore the development of in vitro dissolution profiles for Oxcarbazepine ER Suspension in our case study.
Predicting In Vitro Dissolution of Extended Release Drugs from In Vivo Profiles
Explore our case study on accurately predicting in vitro dissolution of extended-release drugs from in vivo profiles.
Preclinical PBPK Model Translated for Human Exposure Prediction
Unlock insights into translating preclinical PBPK models for accurate human exposure predictions.
Frequently Asked Question?
Comprehensive Answers to Your Inquiries about Biopharmetrics’ Services
What is In Vitro-In Vivo Correlation (IVIVC) and why is it important for my pharmaceutical development?
In Vitro-In Vivo Correlation (IVIVC) is a crucial process in pharmaceutical development that connects laboratory-based experiments (in vitro) with real-life clinical outcomes (in vivo). This correlation allows for accurate predictions of how a drug will behave in humans based on in vitro data. It is essential because it helps in optimizing drug formulations, determining appropriate dosage regimens, and ensuring regulatory compliance. By using IVIVC, Biopharmetrics can expedite your drug development process, enhance efficacy and safety, and reduce time to market.
How does Biopharmetrics utilize IVIVC to optimize drug formulations and dosing regimens?
Biopharmetrics employs a comprehensive IVIVC process that includes in vitro characterization, data analysis, mathematical modeling, and validation. First, we conduct thorough in vitro studies to understand the drug formulation’s properties. We then analyze this data to simulate how the drug behaves under different conditions. Using advanced mathematical models, we establish correlations between the in vitro data and in vivo pharmacokinetic profiles. Finally, we validate these models with additional in vivo data to ensure their accuracy. This systematic approach enables us to optimize drug formulations and dosing regimens effectively, ensuring better clinical outcomes and faster regulatory approval.
What are the key benefits of partnering with Biopharmetrics for IVIVC services?
Partnering with Biopharmetrics for IVIVC services offers several key benefits:
- Accurate Predictions: Our IVIVC models provide precise predictions of drug behavior in humans, reducing the risk of unexpected clinical results.
- Formulation Optimization: We help refine drug formulations to enhance efficacy and stability, improving patient outcomes.
- Regulatory Compliance: Our expertise ensures that your drug development process meets stringent regulatory standards, facilitating smoother approval processes.
- Accelerated Development: By bridging the gap between lab and clinical studies, we streamline the drug development timeline, getting your product to market faster.
Testimonials
Discover What Our Clients Have to Say
We had an outstanding experience working with Biopharmetrics. Their deep expertise in PBPK Modelling & Simulation was evident from the start of the mAb project. The Clinical Pharmacology consultancy support in clarifying queries from the Regulatory Agency and Principal Investigator of our upcoming trial was helpful. The team’s dedication to our project, attention to detail and strict adherence to our timelines helped us achieve our goals ahead of schedule. They worked closely as part of the regular project team and took utmost care in proposing any solutions. We appreciate their commitment and highly recommend Biopharmetrics for anyone seeking PBPK Services." - Battery Bio at Vial
We engaged Biopharmetrics for IVIVC services for our products and continue to work with them, they have been very proactive in proposing solutions like optimizing the dissolution profile, selecting bio-relevant dissolution media based on pilot bio results and shortlisting the pilot batches for pivotal BE studies. Their experience in using mathematical modelling tools ie IVIVC and PBPK for predictions has helped us immensely. They have been an integral part of R&D projects, working closely with CFT’s and aligning the deliverables as per our timelines. We recommend Biopharmetrics to others who are experiencing challenges in their formulation R&D
