Bioequivalence by Raman (MDRS)
What is the purpose of a Bioequivalence study ?
A bioequivalence study is conducted to ensure that a generic drug performs in the same manner as its brand-name counterpart. These studies compare the rate and extent of the active ingredient being absorbed and reaching the site of action, ensuring the generic drug is as safe and effective as the original. Bioequivalence (BE) is critical for regulatory approval and the successful market entry of generic drugs.
FDA recommendation for Bioequivalence studies
Generally, Bioequivalence is assessed using pharmacokinetic studies, which measure drug levels in the blood over time. However, demonstrating the BE of locally-acting products, such as nasal sprays, inhalation products, or topical drug delivery systems, is challenging because traditional pharmacokinetic approaches do not apply. To address this, the FDA recommends using Morphologically-Directed Raman Spectroscopy (MDRS) for in-vitro bioequivalence studies.
Morphologically-Directed Raman Spectroscopy (MDRS)
MDRS combines imaging with Raman spectroscopy to analyze particle size, shape, and chemical composition in detail. This technique provides a deeper understanding of how the physical attributes of a drug affect its bioavailability, making it particularly useful for complex generics. MDRS has been instrumental in regulatory submissions, allowing generic developers to demonstrate essential similarity of formulations while avoiding the expense and time associated with lengthy clinical bioequivalence studies. The FDA’s endorsement of MDRS highlights its importance in ensuring that generic drugs meet the same quality and performance standards as the original products.
Benefits of MDRS
Morphologically-Directed Raman Spectroscopy is especially relevant for pharmaceutical companies and generic drug manufacturers developing or testing complex formulations. By using MDRS as advanced method, these entities can achieve regulatory compliance, reduce development time, and enhance product quality.MDRS (Renishaw Invia) in full alignment with FDA guidelines
At Particle Analytical, we offer bioequivalence studies using MDRS (Renishaw Invia) in full alignment with FDA guidelines. You are more than welcome to reach out to us to discuss your specific product requirements and explore how our expertise can support your regulatory and development goals.How can we help you?
Dr. Fozia Shah, Project Manager
