Animal studies Good Laboratory Practices

Much of what is done (and how it is done) in repeat-dose studies is a response to a number of regulations. Three of these have very broad impact. These are the Good Laboratory Practices requirements, Animal Welfare Act requirements, and regulatory requirements that actually govern study design. 

Preclinical studies Animal studies that support Phase I safety and tolerance studies and must comply with Good Laboratory Practice (GLP). Other preclinical studies are done in discovery research laboratories to support drug efficiency claims. 

Immature female Wistar rats (15 days old) were housed individually in wire mesh cages with solid floors. Artificial light was maintained as a 12/12 h light/dark cycle under standard humidity and temperature conditions. Animals were weaned on conventional standardised laboratory diets. Diet and water were available ad libitum. All animals were acclimatised for 24 h before their injection. The study was conducted in accordance with the OECD Good Laboratory Practice Procedures [21]. 

Experimental use of animals is controlled under Good Laboratory Practice (GLP), and study protocols are submitted to the Animal Research Ethics Committee for approval. Studies using animals can only proceed with the approval of the Ethics Committee, which consists of technical personnel. 

Good Laboratory Practice for Nonclinical Laboratory (Animal) Studies... 

Recent research has indicated that any study using laboratory animals must be conducted based on principles of good laboratory practice. This is particularly important while handling and during termination of laboratory animals. All animals should be treated humanely (Tables 12-6 and 12-7). For more details, refer to Chapter 18. 

Preclinical studies Studies that test a drug on animals and other nonhuman test systems. They must comply with the FDA s good laboratory practices. Data about a drug s activities and effects in animals help to establish boundaries for... 

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