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The Application of the GLP Principles to Short Term Studies - PharmaFacts
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The Application of the GLP Principles to Short Term Studies

Guidances - OECD Guidances

The OECD Principles of GLP are general and not specific to any particular type of test or testing discipline. The initial experience in OECD Member countries in compliance monitoring has been primarily in long-term toxicity studies. Although subject to the OECD Principles of GLP, short-term studies present special concerns to management and compliance monitoring authorities based upon the existence of particular procedures and techniques.

The Revised Principles of GLP define a short-term study as “a study of short duration with widely used, routine techniques” [I.2.3.2]. Short-term biological studies include acute toxicity studies, some mutagenicity studies, and acute ecotoxicological studies.

Physical-chemical studies are those studies, tests or measurements which are of a short duration (typically not more than one working week), employ widely-used techniques (e.g. OECD Test Guidelines) and yield easily repeatable results, often expressed by simple numerical values or verbal expressions.

Typical physical-chemical studies include but are not limited to chemical characterisation studies, melting point, vapour pressure, partition coefficient, explosive properties and other similar studies for which test guidelines exist. However, the regulatory agencies/receiving authorities in Member countries will specify which of these tests should be submitted to them and which should be conducted under the Principles of GLP.

The_Application_of_the_GLP_Principles_to_Short_Term_Studies.pdf