Useful regulatory and informative links

Useful Links


The US Pharmacopeial Convention (USP)

The USP have produced general chapters for design and development of biological assays. The USP chapter of the design and development of biological assays can be found here.

The USP definitions of metrics to be used in method validation submissions document can be found here…  Validation of Compendial Procedures <1225>

The International Council for Harmonisation (ICH)

The ICH in their Validation of Analytical Procedures document have outlined the metrics and characteristics for inclusion as part of registration applications submitted within the EU, Japan and USA. A link to this document can be found here.


Organisation for Economic Cooperation and Development (OECD)

A collection of about 150 of the most relevant internationally agreed guidelines for the testing of chemicals used for regulatory safety testing and in toxicology research can be found here. OECD Toxicology guidelines

Health Technology Assessment

Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)

The PRISMA statement is a reporting guideline designed to improve the completeness of reporting of systematic reviews and meta-analyses. The PRISMA Statement can be found here.