By Cindy Ivey, Surpass, Inc. (from Surpass’ preclinical blog) When planning an FDA GLP preclinical study for a medical device or combination product, it is important to consider the strategy for dealing with test and control article characterization early in the process, to ensure appropriate documentation of article build, sterilization, and testing. The following are […]
Surpass Inc
Model limitations & comparative anatomy for a TAVI/TAVR preclinical study
By Dale Groth, Surpass, Inc. (from Surpass’ preclinical blog) Aortic stenosis is the most common valvular heart disease in the elderly population, with an incidence of 4.6% in adults over 75 years of age (1). Surgical replacement of a diseased aortic valve is the recommended treatment for a symptomatic patient experiencing congestive heart failure, syncope, or chest pain […]
Gathering background for effective preclinical study design
By Mark Cunningham, PhD, Surpass, Inc. (from Surpass’ preclinical blog) Preclinical in vivo research is valuable and often necessary in the evaluation and development of therapeutic products (drugs, medical devices, biologics, and combination products). It is very important that a preclinical study is properly designed, conducted, analyzed, interpreted, and reported to ensure the work provides scientifically valid information […]