GLP Toxicology Study Checklist

What is the difference between GLP and non-GLP toxicology studies?

Good Laboratory Practice is a quality system for how nonclinical safety studies are planned, performed, monitored, recorded, archived and reported. In the US, nonclinical studies that support applications to FDA follow 21 CFR Part 58; elsewhere, studies follow the OECD Principles of Good Laboratory Practice. Pivotal toxicology studies that support first-in-human trials are normally run under GLP. Earlier studies, such as dose range finding, are usually non-GLP and are used to choose the doses for the GLP studies.

Which guidelines shape the toxicology package?

Which studies a program needs is a regulatory decision for each program, made with a regulatory expert. These ICH guidelines frame that decision:

• ICH M3(R2): clinical trials are generally supported by repeated-dose toxicity studies in two mammalian species, one a non-rodent, at least as long as the planned trial
• ICH S6(R1): for biologics, studies use pharmacologically relevant species; two are normal, but one can be enough in justified cases
• ICH S9: a streamlined nonclinical package for drugs intended for patients with advanced cancer
• ICH S7A: the safety pharmacology core battery covers the cardiovascular, respiratory and central nervous systems
• ICH S2(R1): genotoxicity testing

What should be ready before you contact a toxicology CRO?

Test article is the usual bottleneck: how much is available, from which batch, how well it is characterized, and how long it is stable. A validated bioanalytical method is needed for toxicokinetics before the GLP study starts. Dose range finding data should exist to set the GLP doses. Know the clinical route, regimen and planned trial duration, because the toxicology design follows them, and decide whether a pre-IND or scientific advice meeting comes before the design is fixed.

For timing and budget, the IND Timeline Planner and the GLP toxicology cost guide use the same program inputs. For a plain overview of the whole package, read what IND-enabling studies are at guides what are ind enabling studies.

Frequently asked questions

Related free tools

• Pharmacokinetic (PK) Study Planner: Species, dose levels, routes, groups, sampling time points, matrix and PK parameters as a PK study outline.
• Bioanalytical Study Planner: Analyte, matrix, species, sample count, concentration range, method and validation needs as a project brief.
• CDMO Project Planner: Modality, stage, service, process status, scale, analytical and GMP needs and timeline as a CDMO brief.
• All study planners and every free tool on BioBridgeX.

Sources

• 21 CFR Part 58: Good Laboratory Practice for nonclinical laboratory studies
• OECD Principles on Good Laboratory Practice, ENV/MC/CHEM(98)17
• ICH M3(R2): Nonclinical safety studies for the conduct of human clinical trials (2009)
• ICH S6(R1): Preclinical safety evaluation of biotechnology-derived pharmaceuticals
• ICH S9: Nonclinical evaluation for anticancer pharmaceuticals (2009)
• ICH S7A: Safety pharmacology studies for human pharmaceuticals (2000)
• ICH S2(R1): Genotoxicity testing and data interpretation (2011)

This planner organizes requirements. It is not a validated protocol, does not recommend sample sizes, and does not establish GLP, GMP or regulatory compliance. Review every plan with qualified scientific, statistical, ethical and regulatory experts. Facts on this page last checked 27 October 2026.