NETS - Non-GLP Studies
What are non-GLP studies and why are they important in drug development?
Good Laboratory Practices (GLP) is a certification issued by regulatory bodies to ensure that the data submitted to them has been obtained using the proper procedures. GLP certification also ensures that the protocols used were thoroughly documented such that any scientist could follow the protocol and replicate the results. Non-GLP practices are not ‘bad’ or ‘inferior’ – rather, they lack the extensive documentation needed to qualify for GLP certification. For the early phases of pre-clinical research it is unnecessary to adhere to these requirements. Carrying out initial non-GLP studies in the areas of toxicology and pharmacology will preserve both time and funding.
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Related ToolsFDA Guidance: Pharmacology & Toxicology Guidances