Preclinical Toxicity Requirements for Human Drugs *

Gelzer T. : Governmental toxicology regulations: An encumbrance to drug research? Arch. Toxicol. 43:19–26, 1979.

Zbinden G. : Toxicological prerequisites for the study and general release of new drugs. Prog. Toxicol. 1:4–27, 1973.

Hebold G. : Guidelines for the testing of drugs in various countries. In Nordmann N. Merten R. Lommel H. eds. Anatomic and clinical pathology. Amsterdam: Excerpta Medica 1973; pp. 145–159.

Robertson R. T. Majka J. A. Peter C. P. Bokelman D. L. : Effects of prenatal exposure to chlorpromazine on postnatal development and behavior of rats. Toxicol. Appl. Pharmacol. 53:541–549, 1980.

Lasagna L. : Toxicologic barriers to providing better drugs. Arch. Toxicol. 43:27–33, 1979.

Food and Drug Administration. : Good laboratory practices regulations: Management briefings. Post-conference report, 1979.

LePore P. D. : The GLP regulations: purpose and scope. Presented at the Academy of Pharmaceutical Science, Annual Meeting Nov. 15, 1979.