GLP vs. non-GLP

Summary

Regulatory agencies in the United States, Europe and Japan do not require compliance with good laboratory practice (GLP) regulations for in vitro drug metabolism and drug interaction studies. Published industry guidance on the design of drug interaction studies emphasizes these studies be conducted with high standards of quality ensuring reproducibility of data. Sekisui XenoTech offers enzyme inhibition, enzyme induction, drug transport and drug metabolism studies as either non-GLP studies or as studies in compliance with US FDA GLP regulations, US EPA GLP regulations, Japan MHLW GLP regulations or OECD GLP guidance requirements. Sekisui XenoTech's technical paper (right) describes our application of FDA GLP regulations to enzyme inhibition, enzyme induction, drug transport and drug metabolism studies for in vitro and ex vivo test systems and provides a comparison of specific FDA GLP-required elements between an FDA GLP-compliant study and a non-GLP study conducted at Sekisui XenoTech.


GLP vs. non-GLP Studies

Regulatory agencies require that sponsors of regulated products submit evidence of their products safety in research and/or marketing applications. These products include food and color additives, animal drugs, human drugs and biological products, human medical devices, diagnostic products and electronic products. Sponsors and contract research organizations conducting nonclinical safety studies on investigational new drugs must comply with US law and regulations covering Good Laboratory Practice (GLP). FDA uses the data to answer questions regarding:
  • the toxicity profile of the test article
  • the observed no adverse effect dose level in the test system
  • the risks associated with clinical studies involving humans or animals
  • the potential teratogenic, carcinogenic, or other adverse effects of the test article
  • the level of use that can be approved

Good Laboratory Practice regulations (GLP) ensure the quality and integrity of non-clinical safety data; with the aim of ensuring studies supporting investigational new drugs are reliable. The regulations do not aim to evaluate the scientific or technical conduct of studies.

Compliance to GLP regulations is not required for discovery, basic research, screening or any other studies in which the safety of the product is not being assessed. These studies are typically defined as non-GLP studies. Non-GLP studies may not be of lesser quality, they simply may not need to comply with all GLP requirements to ensure quality data. It is important, however that these studies be performed to high standards of quality to ensure reliability of test data. For this reason Sekisui XenoTech applies the same basic GLP principles for planning, training, performance, monitoring, documentation and archiving to non-GLP studies as GLP-compliant studies.

Ultimately it is the sponsor’s decision whether or not to conduct in vitro drug-drug integration studies GLP-compliant or non-GLP, as these studies are not considered safety studies. The decision typically depends on the purpose of the study and/or the desired level of confidence in study results. 

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