In Vitro Study Plan that Checks Every Box
Next Breath provides certified bioequivalence services, working closely with our customers on generic drug submissions to “Get it right the first time”. We know that demonstrating bioequivalence is more than just lab work. Our customers rely on Next Breath to bring regulatory strategy, device understanding and technical know-how. Together we expertly develop the necessary study program based on internationally recognized framework, including the ANVISA guidelines for bioequivalence, to demonstrate the bioavailablilty and bioequivalence of their drug product.
When it comes to complex drug products, Next Breath has bioequivalence expertise for orally inhaled and nasal drug products, locally acting drug products and where a lack of in vitro/in vivo correlation makes it difficult to formulate generic products. Next Breath knows that global approaches to bioequivalence include differing landscapes. We guide our customers on the specific requirements of each agency, such as the ‘traditional’ weighted approach of the FDA, the more stepwise approach adopted by the EMA, and Brazil’s ‘hybrid’ approach.
Next Breath are on top of the Products-Specific Guidances that are frequently published by the FDA. Next Breath are always monitoring new guidances and how concepts can be applied to other drug products.
Utilizing our broad bioequivalence experience and expertise, we develop a program to meet our customer’s specific requirements. Then conduct the relevant experiments according to necessary Draft Guidelines, interpret the test results, and generate a report suitable for inclusion in the regulatory submission.
In Vitro Bioequivalence Services:
Next Breath’s scientists utilize the latest methodologies and instrumentation to provide our customers with the highest quality of analytical analysis of MDI’s, DPI’s, nebulizers, and nasal drug products.