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Rationale for Conducting a Pilot Study Prior to a GLP Preclinical Study

Rationale for Conducting
Many companies setting out to perform Good Laboratory Practice (GLP) studies want to proceed directly into their GLP preclinical study without conducting a preclinical pilot study… https://surpassinc.com/blog/rationale-conducting-pilot-study-prior-glp-preclinical-study/

Test Article Characterization for Combination Product & Medical Device GLP Preclinical Studies

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 characte… https://surpassinc.com/blog/test-control-article-characterization-combination-product-medical-device-glp-preclinical-studies/

Test Article Labels for a Medical Device or Combination Product GLP Preclinical Study

How should test and control articles be labeled for a medical device or combination product GLP preclinical study? Making sure test and control articles are labeled properly is… https://surpassinc.com/blog/labeling-test-articles-medical-device-or-combination-product-glp-preclinical-study/

Test Articles for Medical Device or Combination Product GLP Preclinical Testing

How close to the marketed product should test articles be for medical device or combination product GLP preclinical testing? Medical Device and combination product test article… https://surpassinc.com/blog/test-articles-medical-device-or-combination-product-glp-preclinical-testing/