Bioequivalence

BE is an important evaluation indicator in the drug development evaluation process, which is used to compare the similarity of bioavailability between a new drug and an original drug in vivo. A variety of factors need to be considered comprehensively in actual operation due to national and regional regulatory requirements, the direction of drug research and development are different. Meanwhile, in the design and protocol development of the trial, the specific drug characteristics and patient types need to be fully evaluated and considered to ensure the accuracy and reliability of the test results. In recent years, Quarkmed has more than 100 projects of BE service and abundant experience, and has won the trust and recognition of partners.

Special Project Types (including but not limited to):
• High variability
• Narrow therapeutic index
• Long half-life
• Endogenous compounds

Special Dosage Forms (including but not limited to):
• Modified-release formulations
• Enteric-coated preparations
• Soft gelatin capsules
• Orally disintegrating tablets (ODT)
• Liposomal formulationsLocal delivery (topical/dermal, pulmonary/inhalation)

• Fixed-dose combinations

Special Population Studies (including but not limited to):
• Oncology patients
• Menopausal populations

International Registration Projects (including but not limited to):
• United States
• European Union
• Australia
• ASEAN countries