IN-VITRO BIOEQUIVALENCE STUDIES(IVPT/IVRT STUDIES)
Optimal therapeutic outcome is the goal in the complex pharmaceutical development landscape. Bioavailability is inherently unpredictable, formulation dynamics are complex, and regulatory requirements are strict, which can stall your progress to market. We recognize these challenges at Healios Labs and provide customized solutions to help you enhance your formulations and make your formulation development process simpler.
Our In-Vitro Bioequivalence (BE) studies expertise provides you with the assurance and comprehension needed to achieve smooth Market entry. We test rigorously in accordance with comprehensive analysis, and we confirm that your formulations meet the highest standard of efficacy and safety.
IVPT Studies: Unlocking the Secrets of Bioavailability
As a trusted partner for In Vitro Permeation Testing (IVPT) services, Healios Labs has over 25 years of experience. Our experience spans the complete scope of semi solid products from solutions, foams, sprays, creams, gels and lotions to ointments. In addition, we perform bioavailability studies for branded formulations on par with the industry standards.
We provide a comprehensive approach for an in depth understanding of excipients impact on drug delivery and product quality. We utilize advanced methodologies like rheology, viscosity analysis, microscopic characterization, release rate assessments, and particle size evaluations to deliver critical information that ultimately makes formulations successful.
We design in vitro studies at Healios to minimize clinical risk, such as Biowaiver studies within the regulatory guidelines. In our in-vitro testing with human cadaver skin and other synthetic membranes, we rely on Franz diffusion cells to test with such extensive coverage, supplemented by mass balance studies. We are also able to develop and demonstrate the results to in-vitro permeability tests with state of the art LC/MS-MS and HPLC technologies.
IVRT Studies: Evaluating Release Dynamics
Alongside IVPT, IVRT is an essential service that we offer to help you determine release kinetics of active ingredients from your formulations. It is therefore crucial that you test your products to make sure your products meet not only regulatory requirements but also the desired therapeutic effect.
For our IVRT studies, we meticulously study release profiles to fine tune formulation parameters to ensure we get the best possible release profile with the smallest numer of particles over the life of the device, giving us a better understanding of the device performance under many conditions. Using this data, you can make informed decisions about whether or not to adjust your formula, so your products hit on all safety points and all efficacy points.
At Healios Labs, we specialize in addressing these multifaceted challenges through a comprehensive suite of formulation development services. Our expert team integrates cutting-edge scientific knowledge with innovative problem-solving techniques to transform your ideas into commercially viable products, ensuring that you maintain a competitive edge in the marketplace.