Analysis and Reports
Histological analysis is completed by highly qualified personnel. Study data is compiled and comprehensive study reports are written by professionals with FDA and other regulatory body submission experience. Flexible formats enable short, concise reports for proof of concept work or fully comprehensive reports required for regulatory submissions. Our continuing success has been achieved with a broad range of medical devices, drugs, biologics and combination products.
Board-certified Veterinary Pathologists, and other highly qualified Pathologists and trained Scientists with experience evaluating products and product candidates with a wide variety of pharmaceutical and medical device applications ensure scientifically sound analysis and data interpretation for our clients'studies. Both qualitative and semi-quantitative analysis are offered.
Histion provides GLP-compliant histomorphometry services for a wide variety of applications. Using ImagePro Premier, a state of the art image analysis system, and calibrated images, both hard and soft tissue and residual implant analysis can be completed for any select region of interest identified microscopically as a function of length or area. Some typical applications include:
• Bone and residual implant material area as a function of fusion mass area
• Bone and residual implant material area as a function of bone defect area
• Soft tissue and implant area as a function of defect area
• Bone, fibrous tissue and bone marrow contact as a function of implant perimeter length
• Bone, fibrous tissue and bone marrow area as a function of total available implant area
• Static and dynamic bone measurements for osteoporosis drugs
Our staff is highly trained in histomorphometric techniques on validated systems to enable routine and specialty analysis designed to accurately measure performance for all your product development needs.
Our mission is to provide affordable, high quality services that meet our clients' product development needs in a reliable and timely manner.
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