Bioequivalence Study Center
IBBPS is home to a state-of-the-art Bioequivalence study Centre dedicated to delivering exceptional bioequivalence studies services. At our Bioequivalence Study Centre, we specialize in conducting rigorous studies that demonstrate the equivalence of generic and innovative drug products. It is equipped with cutting-edge technology and led by a team of experienced scientists and researchers; we offer comprehensive solutions tailored to meet your bioequivalence study needs.
Why Choose Us?
- Expertise: Our team brings extensive experience in bioequivalence studies across a wide range of therapeutic areas. We understand the complexities of drug absorption, distribution, metabolism, and excretion (ADME), ensuring thorough analysis and interpretation of study data.
- Advanced Technology: We utilize cutting-edge analytical techniques and equipment (e.g. HPLC, LCMS-MS, GCMS, Spectrophotometers) to assess the drug concentration and establish pharmacokinetic profiles of generic drug products compared to their reference products with accuracy & precision.
- Regulatory Compliance: We adhere strictly to international regulatory guidelines, including those set by the FDA, EMA, WHO, and other global regulatory agencies. Our studies are designed and executed to meet rigorous standards for safety, efficacy, and quality.
- Comprehensive Services: From study design and protocol development to clinical testing and final report submission, we offer end-to-end solutions tailored to meet your specific bioequivalence study requirements.
- Timely Execution: We understand the importance of timelines in drug development. Our streamlined processes and efficient project management ensure the timely completion of studies, supporting your market entry goals.
- Client-Centric Approach: We prioritize clear communication, collaboration, and transparency throughout the study process. Our goal is to build strong partnerships with our clients and deliver results that drive success in generic drug development.
Bioavailability Study Center
We specialize in conducting meticulous bioavailability studies critical for pharmaceutical development. With cutting-edge facilities and a team of experienced scientists, we are committed to delivering precise and insightful results that exceed global regulatory standards.
The BA/BE center comprises of following state-of-the-art section:
Volunteers Healthcare Facility (VHCF)
This facility offers ample rooms and amenities overseen by medical doctors serving as Clinical Research Coordinators and other designated study personnel. VHCF provides the following facilities and services:
- Induction Hall
- Screening Room
- Dedicated Informed Consent Area.
- Drug Administration Area.
- Sample Collection Area.
- Volunteer Confinement Area: Fully air-conditioned rooms with nurse calling system.
- A well-equipped access-controlled Pharmacy for the storage of investigational drug products.
- Sample processing room equipped with Refrigerated centrifuge, -20 and -80 ultra-low freezers.
- Entertainment Area for the entertainment of subjects i.e. equipped with LCD Televisions, indoor games with wi-fi internet access.
- Access control Archive room.
- VHCF is also located in proximity to a fully equipped Intensive Care Unit (ICU).
- Emergency Management room
- Availability of Ambulance at the study site.
- CCTV camera for 24 hrs. Security and safety monitoring throughout the trial.