Creative Animodel is a pioneer in bioequivalence studies and has considerable experience in the conduct of bioequivalence studies. Our clinical specialists are GCP-trained and have participated in numerous international clinical trials. We have fully GLP-compliant bioanalytical facilities with state-of-the-art laboratories managed by highly skilled and experienced scientific professionals. We guarantee our clients with high-quality and high-efficiency reports that comply with all statutory and applicable Global Regulatory Requirements.
Bioequivalence (BE) means that two or more products release their active ingredient into the bloodstream in the same rate and extent. It is determined based on the relative bioavailability of the innovator medicine versus the generic medicine. Bioequivalence studies are initiated to investigate differences between drugs, and they play a key role in the drug development period for both new drug products and their generic equivalents. In addition to requirements for new products, bioequivalence studies are also required by regulations to ensure therapeutic equivalence between a pharmaceutically equivalent test product and a reference product when a manufacturer changes the formulation of an existing product. With over 90% prescriptions in the US being fulfilled by generic drugs, the bioequivalence studies are crucial to the pharmaceutical industry. In order to bring a generic drug to the market, you need to be on speed with many key aspects. Our bioequivalence studies give you an assurance that your studies will benefit from superior resources, world class expertise and, more importantly, provide you confidence that you will be well equipped for the market application.
Bioequivalence Studies at Creative Animodel
Creative Animodel provides a full range of services for bioequivalence studies conducted by our experienced scientists. We have a strong SOP driven culture and ensure compliance with all statutory and applicable Global Regulatory Requirements. With our active volunteer database of 10,000 volunteers (healthy volunteers, special populations and female volunteers), Creative Animodel provides bioequivalence studies on healthy as well as patient population with various dosage forms to meet your requirements. Bioequivalence studies service package includes but is not limited to:
• Medical and scientific consultation throughout the study
• Protocol design and development
• Selection and evaluation of clinical sites
• Fasting and Fed condition studies
• Single and multiple doses
• Cross over and parallel studies
• BE study monitoring
• Data management and statistical analysis
• Study report for submission
Creative Animodel provides high-quality report with lower cost and shorter cycle time to meet your demands for developing pharmaceutical products. All analytical methods are developed and validated in line with current international regulatory requirements with assurance of precision recovery and stability checks. Creative Animodel is the best partner for your drug development.