Bioequivalence by Raman
Bioequivalence studies using Morphologically Directed Raman Spectroscopy (MDRS) – aligned with FDA guidelines
Bioequivalence for regulatory approval
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 is critical for regulatory approval and the successful market entry of generic drugs. It us assessed using pharmacokinetic studies, which measure drug levels in the blood over time. Demonstrating the bioequivalence of locally-acting products, such as nasal sprays, inhalation products or topical drug delivery systems is challenging – traditional pharmacokinetic approaches do not apply.
At Particle Analytical, we specialize in facilitating in vivo bioequivalence studies –tailored to guide you through the FDA’s approval process efficiently. For some cases, where Raman analysis can replace expensive and time consuming in Vivo testing.
FDA recommends Morphologically-Directed Raman Spectroscopy (MDRS)
The FDA recommends using Morphologically-Directed Raman Spectroscopy (MDRS) for in-vitro bioequivalence studies.
The FDA’s endorsement of Morphologically-Directed Raman Spectroscopy, MDRS, highlights its importance in ensuring that generic drugs meet the same quality and performance standards as the original products.
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.
Particle Anaytical as your sparring partner
At Particle Analytical, we offer bioequivalence studies using Morphologically-Directed Raman Spectroscopy (Renishaw Invia) in full alignment with FDA guidelines.
Benefits of MDRS
This advanced method is especially relevant for pharmaceutical companies and generic drug manufacturers developing or testing complex formulations. By using MDRS, these entities can achieve regulatory compliance, reduce development time, and enhance product quality.
Reach out to us to discuss your specific product requirements and explore how our expertise can support your regulatory and development goals.
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