HansenR.W.: The pharmaceutical development process: Estimates of development cost and times and the effects of proposed regulatory changes. In Issues in Pharmaceutical Economics, ChienR. F. (Ed.) D.C. Heath and Company, Lexington, Mass. pp. 151–181, 1979.
2.
GoldenthalE.: Current views on safety evaluation of drugs, FDA Papers13–18, 1968.
3.
Pharmaceutical Manufacturers' Association: General drug safety evaluation guidelines. Document forwarded to member companies, 1980.
4.
Council of the European Communities: Proposal for a council recommendation concerning tests relating to the placing on the market of proprietary medicinal products. Document forwarded to member states, 1980.
5.
Bureau of Drugs, Health Protection Branch, Health and Welfare, Canada. Draft of preclinical toxicological draft guidelines. Document submitted to interested parties, 1979.
6.
ZbindenG.: Toxicological prerequisites for the study and general release of drugs. In Progress in Toxicology, Springer-Verlag, New York pp. 4–27, 1973.
7.
LitchfieldJ.T.WilcoxonF.C.: A simplified method of evaluating dose-effect experiments, J. Pharmacol. Exp. Ther.96:99–113, 1949.
8.
FinnyD.J.: Probit Analysis, Cambridge University Press, Cambridge1971.
9.
LasagnaL.: Drug Toxicity: The problem and challenge, Ann. N.Y. Acad. Sci.123:312–315, 1965.
10.
BalazsT.: Cardiotoxicity of isoproterenol in experimental animals. Influence of stress, obesity and repeated dosing. In Recent Advances in Studies on Cardiac Structure and Metabolism, BujuszE.RosaC. (Ed's.) University Park Press, Baltimore, pp. 770–778, 1972.
11.
BalazsT.: Assessment of the values of systemic toxicity studies in experimental animals. In Advances in Modern Toxicology: New Concepts in Safety Evaluation, MehimanM.ShapiroR.Blumenthal***H. (Ed's) John Wiley and Sons, London Vol. 1(Part 1***):141–153, 1976.
12.
GleasonM.GrosselinR.HodgesH.SmithR.: Clinical Toxicology of Commercial Products, Williams and Wilkins Co., Baltimore, 3rd ed. 1976.
13.
SontagJ.PageN.SaffiottiU.: Guidelines for carcinogen bioassay in small rodents. In DHEW Publication, No. (NIH) 76–801, 1976.
14.
WilsonJ.: Embryological considerations in teratology. In Teratology: Principles and Techniques, WilsonJ.WarkanyJ. (Ed's.) University of Chicago Press, Chicago, 1965.
15.
BarrowM.TaylorW.: A rapid method for detecting malformations in rat fetuses, J. Morphol.127:291, 1969.
16.
AmarosoE.: Placentation. In Marshall's Physiology of Reproduction, Vol. 2, ParksA. (Ed.) Longmans, Green and Co., London, 1952.
17.
GinsburgJ.: Placental drug transfer, Ann. Rev. Pharmacol.11:387, 1971.
18.
LitchfieldJ.: Part XVI. Evaluation of the safety of new drugs by means of tests in animals, Clin. Pharmacol. Ther.3:665, 1962.
19.
KoppanyiT.AveryM.: Species differences and the clinical trial of new drugs: A review, Clin. Pharmacol. Ther.7:250, 1966.
20.
BeinH.EichenbergerE.JungG.PolzerC.StammW.TaeschlerM.: Comparison of experimental and clinical findings: An analysis of clinical trial preparations, Proc. Eur. Soc. Study Drug Toxicity12:179–183, 1976.