Related Experiment Video
Updated: Jan 17, 2026
08:31
Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions
Published on: December 1, 2020
5.5K
Leveraging Biopharmaceutics Bridging Risk Assessment and In Vivo Predictive Tools to Accelerate Immediate Release
Helena Engman1, Sara Carlert2, Maria Hammarberg3
1Global Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, SE-431 83Gothenburg, Sweden.
Molecular Pharmaceutics
|September 22, 2025
Summary
A new Biopharmaceutics Bridging Risk Assessment (BBRA) tool uses physiologically based biopharmaceutics modeling (PBBM) and in vitro models to reduce clinical studies by 70%, improving drug development efficiency.
Area of Science:
- Pharmaceutical Sciences
- Drug Development
- Biopharmaceutics
Background:
- Accelerated oral solid dosage form development requires linking clinical data across stages.
- Traditional clinical bridging studies are time-consuming and costly.
- Predictive tools offer a way to ensure clinical performance while reducing reliance on bridging studies.
Purpose of the Study:
- Introduce a novel Biopharmaceutics Bridging Risk Assessment (BBRA) tool.
- Extend the avoidance of clinical bridging studies beyond BCS classes 1 and 3.
- Mitigate late-stage bioavailability/bioequivalence (BE) failure risks.
Main Methods:
- Utilized physiologically based biopharmaceutics modeling (PBBM) with experimental solubility, dissolution, and permeability data.
- Employed advanced in vitro tools like the TNO transit intestinal model (TIM) to simulate gastrointestinal conditions.
- Developed a decision-tree framework aligned with ICH M9 principles for iterative decision-making.
Main Results:
- The BBRA tool successfully extends bridging study avoidance opportunities.
- Analysis of 32 AstraZeneca cases indicated a potential 70% reduction in clinical studies.
- PBBM and TIM provided enhanced risk assessment granularity and understanding.
Conclusions:
- The BBRA tool, integrating PBBM and TIM, offers a strategic approach to drug development.
- This strategy mitigates late-stage BE failure risks and expedites market introduction.
- The approach ensures effective patient treatments by leveraging in vivo predictions and clinical insights.
Keywords:
advanced in vitro dissolutionbiopharmaceutics bridging risk assessment (BBRA)decision treephysiologically based biopharmaceutics modeling (PBBM)relative bioavailability studyMore Related Videos
Related Concept Videos
01:22Biopharmaceutical Factors Influencing Drug Product Design: Overview
234
Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though...
234
01:22Bioavailability Enhancement: Determination and Conceptual Approaches in Overcoming Bioavailability Problems
189
Body:Bioavailability is a critical pharmacological concept that measures the extent and rate at which an active drug ingredient or therapeutic moiety enters the systemic circulation, remaining unchanged. It's a pivotal factor in determining a drug's efficacy and safety.The Biopharmaceutics Classification System (BCS) plays an essential role in drug development by categorizing drugs into four classes based on their solubility and permeability. This classification aids in understanding drug...
189
01:20Drug Product Performance: In Vitro–In Vivo Correlation
231
In pharmaceutical development, it's crucial to establish a predictive in vitro–in vivo correlation (IVIVC) for two or more formulations to gain a comprehensive understanding of release properties. IVIVC reduces the need for costly in vivo studies and facilitates the establishment of meaningful dissolution specifications with significant cost savings and decreased regulatory burden. Furthermore, a meaningful IVIVC should predict Cmax and AUC within 20%, aligning with FDA guidance while...
231
01:28Preclinical Development: Overview
5.8K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
5.8K
01:13Bioequivalence studies: Biowaivers
229
Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
229
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
407
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
407