Bioequivalence (BE) testing evaluates whether two drug formulations demonstrate similar absorption and systemic exposure, providing critical insights for formulation optimization and development decisions. By comparing pharmacokinetic profiles across oral, topical, transdermal, and injectable dosage forms, these studies enable precise assessment of drug release, absorption, and tissue distribution. BOC Sciences delivers comprehensive preclinical BE services, integrating advanced analytical platforms, including HPLC, LC-MS, and diffusion systems, with validated in vitro and in vivo models. Our expertise spans tablets, capsules, solutions, suspensions, creams, gels, patches, and injectables, supporting generic developers, innovative drug teams, CROs, and biopharmaceutical companies. With high reproducibility, rapid turnaround, and data-driven insights, we ensure actionable results for confident formulation selection.
Our preclinical testing services for oral solid dosage forms include tablets, capsules, and modified/extended-release products. We perform in vitro dissolution and in vivo pharmacokinetic studies in animal models, evaluating drug absorption, release characteristics, and comparative bioavailability between different formulations.
We provide preclinical testing services for oral liquid dosage forms, including solutions and suspensions. Studies focus on absorption kinetics, pharmacokinetic parameter comparison, and formulation performance evaluation, enabling precise assessment of drug release, dispersibility, and bioavailability between test and reference formulations.
Our preclinical testing services for topical and transdermal products cover creams, gels, and patches. We perform in vitro and in vivo skin permeation studies and pharmacokinetic analysis in target tissues, providing detailed evaluation of drug absorption, distribution, and release behavior in preclinical models.
We offer preclinical testing services for intravenous, subcutaneous, and long-acting injectable formulations, including microspheres. Services include blood concentration pharmacokinetics, absorption rate analysis, and multi-timepoint drug release profiling, providing comprehensive evaluation of systemic exposure and bioavailability in preclinical studies.
BOC Sciences offers complete BE testing capabilities, from dissolution and permeation studies to animal PK profiling, ensuring high-quality, reproducible results.
At BOC Sciences, we perform dissolution testing to evaluate drug release rates in various media. This testing is applied to tablets, capsules, and modified or extended-release formulations, providing detailed comparative insights into formulation performance and in vitro release behavior for preclinical bioequivalence evaluation.
We establish in vitro-in vivo correlation models by linking dissolution data with animal pharmacokinetic profiles. This approach predicts in vivo absorption behavior, evaluates formulation performance, and supports preclinical bioequivalence assessment by providing a quantitative understanding of drug release and systemic exposure relationships.
Our permeation and diffusion testing services evaluate drug absorption from topical and transdermal formulations. Using skin diffusion cells or simulated skin models, we measure drug permeation rates, providing detailed data on formulation performance, tissue penetration, and absorption kinetics for preclinical bioequivalence and formulation optimization.
We conduct pharmacokinetic studies in preclinical models, including mice, rats, rabbits, and dogs. Blood samples are analyzed to determine absorption rates, Cmax, AUC, half-life, and other key PK parameters, enabling detailed assessment of systemic exposure and comparative evaluation between test and reference formulations in preclinical bioequivalence studies.
For modified or extended-release formulations, we perform multi-timepoint blood sampling to generate detailed pharmacokinetic profiles. This approach enables precise characterization of concentration–time curves, evaluates absorption dynamics, and provides comprehensive data for comparative preclinical bioequivalence and formulation performance assessment.
We conduct tissue distribution studies for topical and transdermal formulations by analyzing drug concentrations in target tissues and organs. This testing provides detailed insights into drug absorption, local exposure, and distribution characteristics, supporting comprehensive preclinical bioequivalence evaluation and formulation development strategies.
Share your study requirements or product information, and we'll recommend the optimal bioequivalence approach and provide a personalized proposal.
At BOC Sciences, our preclinical bioequivalence platform integrates advanced analytical instruments and validated in vitro/in vivo models to accurately assess formulation performance, drug absorption, and pharmacokinetic behavior. The platform supports comprehensive comparative studies for diverse dosage forms, ensuring high-quality, reproducible, and data-driven results.
To perform precise and reliable BE assessments, we employ a suite of advanced analytical technologies, enabling comprehensive evaluation from in vitro release to in vivo pharmacokinetic analysis. Key Instrumentation Includes:
BOC Sciences provides a comprehensive array of validated in vitro and in vivo models tailored for preclinical BE testing.
| Model Type | Model / System | Application Description |
| In Vitro Models | Dissolution Apparatus (USP I–IV) | For solid oral dosage forms; measures drug release and formulation comparability. |
| Franz Diffusion Cell System | For creams, gels, and patches; simulates skin permeation and diffusion characteristics. | |
| Dynamic Flow-Through System | Supports controlled or modified-release formulations; simulates physiological flow. | |
| In Vivo Models | Rodent Models (Mice, Rats) | Commonly used for oral and topical formulations; PK and absorption studies. |
| Non-Rodent Models (Rabbits, Dogs) | Applied in preclinical PK and BE comparison for oral or injectable formulations. | |
| Tissue Distribution Models | Used to evaluate drug absorption and distribution across target organs or tissues. |
Clients submit study details and testing needs. Our team evaluates objectives and designs a tailored bioequivalence testing strategy.
We develop precise study protocols and perform rigorous sample preparation, including extraction and standardization, ensuring consistency and reliability.
Bioequivalence data is generated using validated high-resolution analytical methods, followed by comprehensive data processing and interpretation.
Comprehensive results and insights are compiled into a clear, actionable report and delivered to clients promptly.
BOC Sciences delivers tailored bioequivalence study services, including plasma concentration analysis and pharmacokinetic profiling. We support generics developers with precise quantification and comparison, ensuring robust data to guide formulation optimization and accelerate development timelines efficiently.
We provide high-resolution metabolite identification and quantification in bioequivalence studies, helping innovative drug teams characterize pharmacokinetics accurately. Our advanced analytical platforms ensure detailed profiling, enabling informed decisions in drug design and process refinement.
BOC Sciences partners with CROs to provide customized analytical and bioequivalence testing platforms. Our integrated workflows enhance analytical precision and throughput, enabling CROs to expand service capabilities while maintaining data integrity and regulatory compliance standards. We help streamline collaborative studies and reinforce competitive advantage through data-driven insight.
BOC Sciences provides academic researchers with customizable bioequivalence testing support, from method development to data interpretation. Our analytical expertise and validated workflows enable precise comparative assessments, supporting publication-quality results and translational research applications. We help institutions translate innovative formulations into validated, data-backed performance outcomes.
Reach out to BOC Sciences to start your bioequivalence program. We deliver high-quality study execution, including study design, sample analysis, and data interpretation, supporting informed decision-making and faster development cycles.
We deliver bioequivalence study results quickly and accurately, helping clients accelerate formulation development while maintaining uncompromised data reliability.
Our testing covers plasma, serum, and tissue samples, providing detailed pharmacokinetic insights for multi-analyte and complex study designs.
Utilizing LC-MS/MS and high-resolution instruments, we quantify trace compounds with exceptional precision and reproducibility across all study samples.
We produce clear, structured reports with visualizations and statistical summaries, simplifying cross-study comparisons and accelerating decision-making processes.
Client Needs: A pharmaceutical company developing oral small-molecule tablets required comparative pharmacokinetic profiling to ensure candidate formulations exhibited equivalent absorption and systemic exposure, critical for early-stage formulation prioritization.
Challenges: The client struggled with batch-to-batch variability in dissolution profiles, making systemic exposure predictions unreliable. Traditional assays failed to capture subtle absorption differences, slowing formulation selection.
Solution: BOC Sciences applied a comprehensive BE testing workflow integrating optimized analytical sampling and LC-MS/MS quantification. Multi-point pharmacokinetic profiling with statistical modeling enabled precise comparison of systemic exposure across formulations.
Outcome: Delivered high-resolution comparative pharmacokinetic data, highlighting absorption differences and identifying optimal tablet formulations. The client accelerated formulation prioritization with confidence, reducing iteration cycles and resource expenditure.
Client Needs: A biopharmaceutical developer required robust bioequivalence assessment of multiple injectable small-molecule candidates to guide formulation selection and dosage optimization.
Challenges: The client faced inconsistent absorption patterns due to variable excipients, producing unreliable pharmacokinetic data and complicating candidate ranking for efficient formulation selection.
Solution: BOC Sciences implemented a tailored BE testing strategy using sensitive LC-MS/MS quantification and structured multi-point sampling. Data normalization and statistical analysis ensured reproducibility across formulations.
Outcome: Provided reliable comparative exposure profiles for all injectable candidates. The client could confidently select promising formulations, streamline development prioritization, and reduce uncertainty in downstream pharmacology.
Client Needs: A pharmaceutical company developing extended-release (ER) capsule formulations sought precise bioequivalence testing to evaluate systemic drug exposure and release kinetics among multiple prototype formulations.
Challenges: The client observed inter-batch variability in drug release rates, and traditional assays inadequately reflected in vivo exposure, delaying confident selection of lead ER formulations.
Solution: BOC Sciences conducted structured BE testing integrating high-resolution pharmacokinetic sampling and LC-MS/MS analysis. Multi-point exposure profiling and statistical modeling provided detailed insights into absorption kinetics.
Outcome: Delivered robust bioequivalence data distinguishing high-performing ER formulations. The client selected optimal candidates efficiently, reduced development iteration cycles, and made informed, data-driven formulation decisions.
Bioequivalence studies are designed to evaluate whether two drug formulations exhibit similar absorption rates and extents in the body. By comparing pharmacokinetic parameters between a reference drug and a generic or alternative formulation, these studies help determine if the two products can be considered equivalent in vivo. Such studies provide critical insights for formulation development and optimization. BOC Sciences offers expertise in designing and executing BE study protocols, providing tailored experimental design and data analysis support.
Bioavailability studies primarily measure how much and how quickly a drug is absorbed into the bloodstream from a single formulation. Bioequivalence studies, on the other hand, compare the absorption profiles of two formulations to confirm whether they are essentially equivalent. In short, BA studies assess “how efficiently a drug enters the bloodstream,” while BE studies verify “whether two formulations perform similarly in vivo.” Understanding this distinction is critical for rational drug development and formulation strategy.
BE (Bioequivalence) and BA (Bioavailability) studies are both essential tools for evaluating drug behavior in vivo. BA studies provide quantitative information on drug absorption from a single formulation, while BE studies compare absorption between different formulations to determine interchangeability. Well-designed BE/BA studies reduce development risks and provide actionable data for formulation improvement. BOC Sciences has mature processes for BE/BA studies and can provide professional solutions tailored to the properties of your drug.
The primary objective of a bioequivalence study is to confirm that two drug formulations have comparable absorption profiles in the body, ensuring that a substitute product delivers predictable efficacy. By precisely measuring pharmacokinetic parameters such as Cmax and AUC, companies can make informed decisions in formulation development and optimization, directly enhancing product competitiveness.
BE studies provide critical scientific data to guide formulation design and the development of alternative drug products. For companies aiming to optimize product lines or accelerate market entry, these studies help reduce development risks while enhancing product reliability and competitiveness. BOC Sciences offers end-to-end professional services, from study design and execution to data analysis, enabling companies to efficiently generate key data for decision-making.
The bioequivalence study services provided by BOC Sciences offered reliable and highly accurate analytical data. Their attention to experimental design and meticulous documentation allowed us to draw robust conclusions with confidence. Their professional approach significantly enhanced our internal data evaluation processes.
— Dr. M., Senior Scientist, Pharmaceutical Research Firm
BOC Sciences' bioequivalence studies stood out for their thorough methodology and detailed data reporting. The team's systematic approach and clear presentation of results facilitated our project assessments and internal decision-making, ensuring we could move forward with strategic confidence.
— Dr. S., Head of R&D, Specialty Pharma Company
The bioequivalence testing conducted by BOC Sciences consistently produced highly reproducible and precise data. Their expertise in study design and analytical execution provided us with reliable datasets that strengthened our internal evaluations and comparative analyses.
— Dr. T., Principal Scientist, Mid-sized Biopharmaceutical Company
BOC Sciences' bioequivalence study services deliver not only precise measurements but also insightful interpretation of analytical results. Their structured data presentation and methodical testing process greatly supported our internal project reviews and cross-team collaborations.
— Dr. R., Director of Analytical Development, Emerging Biotech Company
