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Pre-clinical trials involes the study of pharmacological and toxicity studies using animals. Therefore, these studies are regulated under Good Laboratory Practice with strict guidelines. In US, scientists follow FDA 21 CFR Part 58 'Good laboratory practice for nonclinical laboratory studies' to write a protocol.

Good Laboratory Practice (GLP)

GLP is the standards for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for food and color addictives, animal food additives, human and animal drugs, medical devices for human use, biological products and electronic products. Compliance is intended to assure the quality and integrity of these data. GLPs cover topics such as animal care and documentation, lab methods, procedures, archiving of infromation and independent revire by a quality assurance unit. (MeduMaze)

  1. MeduMaze. Supplemental Information and Alphabetical Glossary of Terms, Drug Development & Approval Game (pp 14)

  2. Ng, R. (2005). Drug Development and Preclinical Studies. Drugs, John Wiley & Sons, Inc.: 107-138.

  3. FDA (2015). "CFR - Code of Federal Regulations Title 21." from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=58.

Reference

FDA 21 CFR Part 58 Good Laboratory Pratice for Nonclinical Laborotory studies covers:

GLP

When the pre-clinical trial begins,it needs to comply with

GLP

Website edited by Chloe,

last updated on November 2015

MONASH University

Pharmacy and Pharmaceutical Sciences

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