Bioequivalence Study Design
Bioequivalence and Bioavailability studies are complex, thus collaborating with a competent and reliable clinical partner is critical for successful study design and completion. BioPharma Services is a full-service clinical research organization (CRO) that competently and efficiently designs and performs human clinical trials for our clients’ drug development programs. We provide unparalleled support for all aspects of bioequivalence and bioavailability studies, including study design, recruitment, clinical conduct, bioanalysis, statistical support, and regulatory guidance.
What are Generic Drugs and Bioequivalence Studies?
Generic drugs are created with the goal of having the same dosage form, quality, strength, safety, administration route, performance characteristics, and intended use as their reference brand-name drugs. A key component of evaluating generic drug candidates is the assessment of their bioequivalence to the corresponding reference drugs. In addition, bioequivalence studies can also be conducted to assess changes in drug formulation or manufacturing processes that occur during drug development or post-approval.
The term bioequivalence indicates that there is no significant difference in the rate and extent to which an active ingredient or moiety in a pharmaceutical equivalent or alternative becomes available at the site of action when delivered at the same molar dose as a reference drug and under similar conditions.
Requirements & Considerations for Bioequivalence Study Design
When doing bioequivalence study design, the need to evaluate drug absorption and differentiate between formulations should be considered. A two-way, single-dose, crossover design with randomly assigned sequences is commonly used in bioequivalence studies because it limits the possible interference of patient-specific factors. A long washout period should be planned when using a crossover design.
Other possible study designs include parallel and replicate bioequivalence studies. The selection and recruitment of study participants, as well as the required sample size, should be planned carefully.
Pharmacokinetic Parameters Used to Assess Bioequivalence
This includes maximum (peak) concentration (Cmax), the area under the curve t (AUCt), AUCinf, and the time to reach Cmax (Tmax). Cmax is the maximum observed concentration (most commonly in blood) and is an indicator of the rate with which the drug becomes available at the target site.
To assess Cmax appropriately, adequate blood sampling time points should be selected. The AUC measures the extent of drug exposure. AUCt is an indicator of the drug exposure to the body until the final sampling time point. In contrast, AUCinf is an indicator of the total drug exposure to the body from administration until drug elimination.
In instances where the Tmax differs between the two compared products, additional data analyses of partial AUCs, clinical studies, or an exposure-response evaluation may be needed to assess the bioequivalence.
Most bioequivalence studies are performed under fasting conditions unless there are concerns about the drug tolerability without food, in which case the study may be conducted under fed conditions. If a pharmacokinetic bioequivalence studies are not feasible because the drug levels cannot be measured or are not relevant, pharmacodynamic bioequivalence studies can be planned.
Extensive Multidisciplinary Team for Bioequivalence Studies
BioPharma’s bioequivalence team includes pharmacokinetic scientists, clinical investigators, clinical operation specialists, bioanalytical scientists, statisticians, and regulatory scientists. Its members are selected among the CRO’s 250-plus multidisciplinary experts, including at least 8 Ph.D. graduates. Our medical team is also supported by Dr. Isabella Szeto and Dr. Artan Markollari, who have served as PIs in numerous clinical trials. Our PIs have more than 50 years of combined experience.
Dr. John Oldenhof
Chief Scientific Officer
Dr. John Oldenhof has extensive senior management experience in Phase 1 clinical pharmacology, product development, biostatistics, clinical trial data management, and regulatory and scientific affairs.
Dr. Fathi Abuzgaya
Chief Medical Officer & Principal Investigator
Our chief medical officer (CMO) Dr. Fathi Abuzgaya has over 15 years of experience serving as a Principal Investigator (PI) or sub-investigator for over 100 clinical trials in a wide range of therapeutic areas.
Proficiency With Various Formulations and Routes of Administration
Changes in the formulation of drug candidates may be one of the reasons for the performance of bioequivalence studies. BioPharma has extensive experience backed by our internal experts and external collaborators to assessment various drug formulations.
Safe State-of-the-Art Clinical Facilities
BioPharma Services has established two state-of-the-art Phase I clinical centers in Toronto, Canada, and St. Louis, Missouri. They have all the necessary infrastructure for conducting bioequivalence studies to support both generic and hybrid drug filings and 505(b)(2) New Drug Applications.
Participant safety is the highest priority of our PIs and staff working in both centers. Our centers’ infrastructure and equipment include dedicated Phase 1 intensive monitoring units, 24-hour monitoring, a telemetric option, a crash cart, a limited number of beds, and a nursing station in the rooms. In addition, our clinical team includes highly qualified and broadly experienced PIs, ER physicians, anesthesiologists, and ALCS-trained staff.
Modern In-House Bioanalytical Capabilities
BioPharma has established an in-house bioanalytical laboratory that can analyze samples from bioequivalence and bioavailability studies with high sensitivity and specificity.
Passing Batch Rate
Led by Dr. Nicki Hughes, who has 20-plus years of experience in bioanalytical research. Our in-house laboratory is equipped with a modern liquid chromatography with tandem mass spectrometry (LC/MS/MS) platform to carry out analyzes in various matrices. We continue to develop novel LC-MS/MS-based assays to meet client-specific bioanalytical needs.
Dr. Nicki Hughes
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