Category: Uncategorized

GLP Practices

What are the GLPs?

In the United States, Good Laboratory Practice, aka “the GLPs”, describes FDA regulation 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies. This regulation is for in vivo or in vitro experiments where test articles (such as medical devices, biological products, pharmaceutical products, or any other article subject to regulation under the Food, Drug, and [...] Full Story
Sample Preparation

Proper Sample Preparation for Biocompatibility Testing

Sample preparation is one of the most critical steps in a preclinical testing program for a medical device. This initial step is often overlooked or unclear to sponsors, and if not thoroughly strategized up-front, can lead to unnecessary delays or unfavorable results in testing programs.

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