BA / BE Study
People first, Science forward.
BA / BE Study
The Bion Clinicals is a dedicated BA/BE CRO, designed to cater the advance regulatory market like US and Europe. Our team is specialized in Bioavailability (BA) and Bioequivalence (BE) studies, offering a comprehensive range of services that help pharmaceutical, biotechnology, and generic drug companies optimize their formulations and meet regulatory requirements.
Our expertise ensures study design meet safety, efficacy, regulatory standards and accelerating the path to market. Our state-of-the-art BA laboratories offer bioanalytical testing using methods such as LC-MS/MS (Liquid Chromatography-Mass Spectrometry) to accurately measure drug concentrations in biological samples, providing precise data for BA/BE studies.
Key services includes:
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Special Population BA/BE Studies:
We conduct studies in special populations such as Healthy Males, Healthy Females, Healthy post-menopausal Females, Elderly subjects, Obese subjects. -
Expertise in Method Development and Validation:
Our team of skilled scientists brings extensive experience in method development and validation of all small and large molecules to endogenous and biologics. -
Advanced Analytical Platforms:
We utilize cutting-edge technology and validated bioanalytical platforms for precise measurement of drugs and biomarkers, ensuring data accuracy. -
Customized Solutions:
We understand that each drug and clinical trial is unique, and we offer tailored PK/PD study solutions to meet your specific research needs. -
Regulatory Insight:
With a deep understanding of global regulatory requirements, we ensure our studies meet the standards set by authorities such as the FDA, EMA, and ICH.
