Emmace Consulting will participate in yet another project (Grant #75F40119C10154) sponsored by US Food and Drug Administration (FDA). The company will use its methods and models to conduct studies that may challenge current pharmacopeia methods. The project spans two years and will be carried out in collaboration with the University of Florida.
Emmace Consulting has internationally recognized expertise in inhalation studies. The company will carry out studies to simulate how the dose of medicine from a range of commercial inhalers reaches the lungs under various conditions and in different patients. One aim is to explore whether a new method of analysis, which is more clinically relevant and potentially more robust than the method described in current pharmacopeia, should replace it.
The company will apply its unique methods and models in the studies, including various oral cavity castings and a “mechanical hand” that applies standardized hand pressure when dosing and can be actuated at any point in the inhalation maneuver. Emmace Consulting has recently participated in FDA-funded research projects since 2015, such as grant #U01FD004943, in which the University of Florida is the Principal Investigator (PI).
“We are immensely pleased to take part in a second research project. It shows that our expertise is of the highest quality and meets the requirements that the FDA expects. The comprehensive project will account for a substantial portion of our revenue over a two-year period,” says Mårten Svensson, CEO and founder of Emmace Consulting.
For more information, please contact: Mårten Svensson, CEO and founder of Emmace Consulting, firstname.lastname@example.org, telephone: +46 (0)709-59 45 53
Emmace Consulting: Emmace Consulting offers excellence in advising and performance testing of pharmaceutical products on a CRO-basis. Our strengths are in the following areas:
- Traditional testing of inhalers (DPI, pMDI, and nebulizers) including cascade impaction, laser diffraction, and delivered dose uniformity characterization according to US and EU Pharmacopeias;
- Experimental determination of expected lung dose from inhalers by using anatomically realistic mouth-throat inlets in combination with patient-like inhalation profiles (best-in-class in-vitro/in-vivo comparisons);
- Strategic advising in CMC and clinical support and in lung dose modeling;
- Software for the prediction of particle delivery to the lung – Mimetikos Preludium™
LUND, Sweden, December 03, 2019.