Bioequivalence and Bioavailability Studies
Industry Leading Bioequivalence (BE) Services
Generic drugs account for almost eight of every 10 prescriptions filled in the United States and cost approximately 80-85% less than their brand-name counterparts. Notably, generic drugs have to comply with strict regulatory Bioequivalence requirements for generic products regarding their bioequivalence to the corresponding brand-name drug, bioavailability, and overall quality. The complexity of the regulatory process for generic drug approval is illustrated by the high number of Product-Specific Guidances for Bioequivalence Drug Development posted or revised by the U.S. Food and Drug Administration (FDA) both for drugs and complex products, such as metered dose inhalers during 2021. BioPharma Services Inc., a full-service Clinical Research Organization (CRO) that has successfully completed over 2,000 clinical trials, offers first class bioequivalence services and comprehensively yet efficiently supports our clients with their bioequivalence and bioavailability studies and the development of our generic products.
Talented Multidisciplinary Team
Our accomplished team of clinical investigators, pharmacokinetic scientists, and clinical operation specialists has vast experience with all stages of bioequivalence and bioavailability studies. Moreover, our bioequivalence and bioavailability team works in close collaboration with our talented bioanalytical scientists, statisticians, and regulatory professionals to comprehensively support all aspects of our clients’ bioequivalence and bioanalysis programs.
State-of-the-Art Facilities & Large Database of Study Volunteers
BioPharma Services has two state-of-the-art first in human clinical trial sites, located in Toronto, Canada, and St. Louis, with all necessary infrastructure and expertise for phase 1 clinical trials, first in human studies and bioequivalence and bioavailability studies to support both generic and hybrid drug filings and 505(b)(2) New Drug Applications. In addition, BioPharma has established a volunteer database with over 18,000 potential study participants, including both male and female healthy volunteers and special populations, that enables fast and efficient recruitment.
Experts in Data Submission
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To Learn More about the Bioequivalence and Regulatory requirements for generic products, speak with one of our industry leading experts.
We have extensive expertise in the development and evaluation of a wide range of drug formulations. We can competently and efficiently conduct studies on:
- Solid oral formulations
- Solid oral dosage forms for immediate release, extended release and modified release
- Orally disintegrating tablets
- Solid liquid formulations
- Inhalation products
- Transdermal patches
- Long-acting depot injections
- Creams, suppositories and ointments
Outstanding End-to-end Service for Bioequivalence and Bioavailability Studies
BioPharma can competently support the complete cycle of bioequivalence and bioavailability studies from bioequivalence study design and protocol inception to the issuance of the final clinical study report.
Competent and Efficient Study Execution
Our accomplished team of pharmacokinetic scientists, clinical operation specialists, and clinical investigators work together to ensure the competent and timely execution of bioequivalence and bioavailability studies that adhere to the principles of Good Clinical Practice (GCP).
Strict Quality Control
BioPharma’s quality assurance experts and quality control processes warrant the acquisition of high-quality scientific data and excellence of the conducted clinical research.
Competent In-House Bioanalysis of Samples Derived From Bioequivalence Studies
Our in-house bioanalytical laboratory enables the rapid and reliable analysis of samples derived from bioequivalence and bioavailability studies.
Statistical Support
Our team of accomplished biostatisticians provides excellent biostatistical services and programming support for our clients’ generic drug development programs.
Regulatory Guidance
BioPharma’s regulatory professionals ensure that our clients’ bioequivalence and bioavailability studies comply perfectly with regulatory bioequivalence requirements for generic products. Our in-house scientific and regulatory expertise is illustrated by BioPharma’s successful completion of numerous regulatory inspections from the FDA, Health Canada, European Medicines Agency (EMA), UK Medicines and Healthcare products Regulatory Agency (MHRA), Brazilian National Health Surveillance Agency (ANVISA), World Health Organization, French National Agency for the Safety of Medicines and Health Products (ANSM), Danish Medicines Agency (DKMA), and Standards Council of Canada.
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