Good laboratory practice (GLP) regulations became effective in 1979 ... According to Part 58, raw data encompasses all original observations in a non-clinical laboratory study, which is necessary for ...

Good Laboratory Practice (GLP): is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies that are intended to support research or marketing permits for ...

The Good Laboratory Practice (GLP) toxicology study is a requirement for an FDA Investigational New Drug (IND) filing. Ocular tolerance includes observations at dosing, general clinical ...

today announces the initiation of Good Laboratory Practice (GLP) toxicology studies of its lead oncology program, QN-302, a G4-selective transcription inhibitor currently in development for the ...

Title 21 CFR Part 58 provides guidance on Good Laboratory Practice (GLP) for executing non-clinical laboratory studies that support applications for research permits for Food and Drug ...

Before the safety and efficacy of a new vaccine can be evaluated in a Phase I clinical trial with human subjects, it must first undergo non-clinical safety evaluation ... Phase 1 must be conducted ...

Perhaps the best acronym for guiding researchers through proper documentation, “ALCOA” has its roots in the federal regulations governing good laboratory practice for non-clinical laboratory ...

However, most stem cell use in regenerative medicine remains in preclinical stages with only a few clinical uses ... applicable practices relevant to all cell culture, such as good laboratory practice ...

The Good Laboratory Practice ... the study protocol and perform in-process audits of study conduct. These in-process audits may include test article preparation, dose administration, clinical ...