GLP compliance
Good Laboratory Practice, a quality system for non-clinical laboratory studies. GLP-compliant studies follow standardized procedures for planning, performing, monitoring, and reporting, ensuring data integrity for regulatory submissions.
Frequently Asked Questions
What is GLP compliance?
Why is GLP compliance important in peptide research?
Related Terms
The research stage involving in vitro (cell culture) and in vivo (animal) studies before human clinical trials begin. Most peptides outside GLP-1 agonists remain at this evidence stage.
IND (investigational new drug)An application submitted to the FDA before human clinical trials can begin. The IND includes preclinical data, manufacturing information, and the proposed clinical trial protocol.
ICH guidelinesInternational Council for Harmonisation guidelines that unify pharmaceutical regulatory requirements across the US, EU, and Japan. Cover drug quality, safety, efficacy, and multidisciplinary topics.