In Vitro − In Vivo correlation IVIVC Equipment

In Vitro − In Vivo Correlation (IVIVC), as defined by the FDA, is a predictive mathematical model describing the relationship between the in vitro property of a dosage form and relevant in vivo response. The FDA has provided little to no guidance on IVIVC practices, but there is growing interest including an FDA draft guidance using IVIVC methods for a generic drug development.

A basic system is comprised of two more-realistic elements to give a more accurate representation of how a drug may behave in a specific type of patient’s respiratory system: the first is a more anatomically representative mouth and throat feature, and the second is a more representative breathing pattern.

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Some TSI instruments will help answer research questions or provide compliance data. Others will enable manufacturing improvements or help companies protect their workers with precise measurements of air quality, respirator fit, dust exposure or other safety factor.
Our engineers are continuously innovating, developing, and improving. See the latest products and solutions from TSI.

Aerosol Generators & Dispersers

Aerosol generators and dispersers play a vital role in producing the defined aerosol required for an array of aerosol testing, production, and research. Applications requiring aerosol generation are very diverse, and include, but are certainly not limited to, filter testing, deposition of nanoparticles onto surfaces, vacuum-cleaner performance tests, and calibration of aerosol instruments.

Generic Drug Development Equipment

The USP and FDA provide blueprints for many methods and monographs to assist in accelerating regulatory acceptance.

To name just a few, there are well known and accepted generics for albuterol, fluticasone propionate, Salmeterol, or combinations. Another recent generic draft guidance from the FDA is Beclomethasone Dipropionate, utilizing an IVIVC approach.

There are also unique testing aspects to OINDPs that are outside of the focus of APSD and DDU tests. MSP, a Division of TSI, carries a full equipment set to perform dissolution testing, gravimetric testing, spray force testing, and testing the “cold Freon” effect. These types of products are also featured in the Copley Catalog.

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TSI Instruments Ltd

Stirling Road, Cressex Business Park, High Wycombe, Buckinghamshire, HP12 3ST, United Kingdom

TSI Ltd serves a global market by investigating, identifying & solving measurement problems. As an industry leader in the design & production of precision measurement instruments, TSI partners with research institutions & customers around the world to set the standard for measurements relating to Respirator Fit Testing, aerosol science, air flow, indoor air quality, fluid dynamics and biohazard detection. With headquarters based in the U.S. & field offices throughout Europe & Asia, TSI has established a worldwide presence in the markets we serve.

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