This paper provides a brief review of the implementation of good laboratory practices (GLP) by European companies with respect to toxicity, toxicokinetic, pharmacodynamic, and analytical (physico-chemical) studies.
Organisation for Economic Cooperation and Development.“Principles of GLP.” Annex II to Council Decision C(81)30 of 12th May 1981.
2.
Food and Drug Administration.“Final report of Investigation of G. D. Searle Company.” March 21, 1976.
3.
Food and Drug Administration.“Proposed regulations for Good Laboratory Practice”Federal Register. November 19, 1976.
4.
Food and Drug Administration.“Results of the Nonclinical Toxicology Laboratory Good Laboratory Practices Pilot Compliance Program.” Document PB 272 270. September 1977.
5.
Food and Drug Administration.“Nonclinical laboratory studies: Good Laboratory Regulations.”Federal Register. December 22, 1978.
6.
German Ministry of Health.“Bekanntmachung der OECD-Grundsätze der GLP.”Bundesanzeiger. March 2, 1983.
7.
Japanese Ministry of Health..
8.
EC Council.“Council Directive 65/65 on the approximation of provisions. relating to proprietary medicinal products.”.
9.
EC Council.“Council Directive 75/318 on. standards and protocols in respect of the testing of proprietary medicinal products.”.
EC Council.“Council Directive 87/18 on the application of the principles of GLP and the verification of their application for tests on chemical substances.”.
12.
EC Council.“Council Directive 88/320 on the inspection and verification of GLP.”.
