BA | BE Studies - CEBIS

CEBIS India understands your need for innovative solutions to accelerate your products time to market. Dedicated team working in harmony with complete adherence to local and international quality standards is the commitment of our team.

We aim to be a premier service provider of clinical services, believe in providing safe and ethical research solutions for Bioequivalence - Bioavailability studies.

CEBIS’s significant experience in carrying out a full range of bioavailability / bioequivalence studies has helped us to understand the complete generic development process. Our experience and expertise provides confidence to our sponsors that their project will be completed ethically, professionally and with most expeditious economic way possible. Our good infrastructure provides a quick accommodation of your project for male / female or special populations.

The bioavailability and bioequivalence studies are conducted at our facilities in strict compliance with national and international regulatory guidelines that are monitored by independent quality assurance team. CEBIS India conducts BA/BE study as per CDSCO as well as ICH (E6)/ EMEA/ASEAN/US FDA/UK MHRA/NPRA (Malaysia)/ANVISA (Brazil) etc. guidelines as desired by the sponsor. For conducting BA/BE study the protocol is prepared in consultation with the sponsor and clinical pharmacologist. The healthy human volunteers are accommodated in a air-conditioned CPU(Clinical Phamacological Unit) of CEBIS India. The audio-video recording of informed consent process is carried out in presence of either principal investigator or study co-ordinator, CRA and other related staff prior to BA/BE study. The paramedics collects the blood samples from the volunteers as per the blood sampling points stated in the protocol and stored in a deep freezer at -70°C -20°C .

At CEBIS,we conduct the following type of studies :

• Single and multiple dose studies in fasting and fed conditions in healthy subjects
• Drug-drug interaction, drug-food interaction
• Special | Patient Population (PK | PD) studies
• Pharmacokinetic / Pharmacodynamic studies in Healthy subjects
• Postmenopausal healthy subject studies.
• Drug – Drug Interaction studies.
• Clinical end point BE studies in patient population.

Our expertise with various formulations includes :

• Solid Oral Formulations and various modified released products.
• Orally Dispersible Formulation.
• Nasal spray and rectal creams.
• Liquid Formulations Suspensions & Syrups.
• Parenterals (IM, IV & Subcutaneous).
• Dermal Patches (In alliance with channel partners).

The volunteer recruitment team has created a good data base of +1500 healthy volunteers for the successful completion of the studies. The database is being continuously getting updated to meet your needs.

Our clinical pharmacology unit (CPU) is equipped with:

• 140 beds arranged in two clinic study areas.
• 22,500 square-foot clinic area
• Two -bed state of art Intensive Care Unit with cardiac monitoring
• 24/7 dedicated doctors on board.
• Dedicated phlebotomists, nurses Doctor and para medical staff.
• Refrigerated Centrifuges
• -70°C deep freezers storage facility