Case Studies
Explore how preclinical PBPK models are refined for accurate human exposure predictions and dosage regimen determination.
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.
Our Services
Precision Solutions for Drug Development
With a commitment to innovation and patient-centricity, we empower pharmaceutical companies to bring life-changing medicines to patients worldwide, driving progress and improving healthcare outcomes.
Our Approach
Integrated Approach to Quality-Centric Drug Development
Our methodology integrates systematic and quantitative techniques, emphasizing clinical relevance, to ensure optimal product quality control and enhance patient outcomes.
Multivariate Models
Utilizing multivariate models to link raw material attributes, providing insights into their impact on product dissolution.
In Vitro/In Vivo Correlation (IVIVC)
Establishing connections between in vitro and in vivo data, ensuring clinical relevance in drug development.
Predicting Exposure Ratios
Utilizing models to predict exposure ratios between future and clinical batches, defining limits for consistency.
Raw Material Quality Control
Setting clinically meaningful limits for raw material quality control to ensure bioequivalence with clinical batches.
Optimizing Drug Product Quality
Applying mechanistic understanding through PBBM to optimize drug product quality attributes for enhanced safety and efficacy.
Application of PK/PD Modelling
Developing PK/PD models to address hypothetical scenarios, providing solutions for informed decision-making
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
Clinical Trial Optimization
We design and optimize clinical trials, ensuring efficient data collection and robust evidence generation. Our expertise streamlines the drug development process.
Regulatory Strategy
We navigate complex regulatory landscapes, providing strategic guidance to meet requirements. Our insights facilitate successful submissions and approvals.
Scientific Communication
Our team communicates research findings effectively, bridging gaps between stakeholders. Clear, evidence-based communication drives informed decisions.
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.
Risk Assessment
We assess risks associated with drug development, identifying potential pitfalls early. This proactive approach minimizes setbacks and accelerates progress.
Patient-Centric Approach
We prioritize patient needs, ensuring that drug development aligns with real-world clinical practice. Patient perspectives guide our work.
Frequently Asked Question?
Understanding Our Services Through Case Studies
What is the purpose of preclinical PBPK models in drug development?
Preclinical Physiologically Based Pharmacokinetic (PBPK) models are used to simulate the absorption, distribution, metabolism, and excretion of drugs in animals. These models are crucial for predicting how a drug behaves in humans, helping to refine dosage regimens and improve safety and efficacy before clinical trials.
How do you refine preclinical PBPK models for human application?
We refine preclinical PBPK models by integrating data from animal studies and using advanced algorithms to simulate human physiological conditions. This process involves adjusting model parameters to align with human biology, ensuring accurate predictions of drug exposure and response in humans.
Can you explain the case study on Oxcarbazepine ER Suspension?
In the Oxcarbazepine ER Suspension case study, we developed an in vitro dissolution profile to predict how the drug releases over time. This profile helps in understanding the drug’s behavior in the human body, ensuring consistent and controlled drug delivery for extended therapeutic effects.
What insights were gained from predicting in vitro dissolution of extended-release drugs?
The case study on predicting in vitro dissolution from in vivo profiles demonstrated the ability to accurately forecast how extended-release drugs dissolve and release their active ingredients over time. This prediction is essential for ensuring that the drug maintains its intended therapeutic effect throughout the dosing period.
How do your case studies benefit pharmaceutical development?
Our case studies provide detailed insights into the methodologies and outcomes of refining PBPK models and dissolution profiles. These examples highlight successful strategies and potential challenges in drug development, offering valuable knowledge that can be applied to future projects to enhance drug safety, efficacy, and regulatory compliance.
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
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