Association of the British Pharmaceutical Industry (ABPI) (1985) Guidelines on Data Needed to Support the Administration of New Chemical Entities to NonPatient Volunteers. London: ABPI. The European Agency for the Evaluation of Medicinal Products (EMEA) (1998) ICH M3 Non-Clinical Safety Studies For The Conduct of Human Clinical Trials for Pharmaceuticals. CPMP/ICH/286/95 Food and Drug Administration (FDA) (1968) Synopsis of General Guidelines for Animal Toxicity Studies. Igarashi T (1994) The duration of toxicology studies required to support repeated dosing in clinical investigation—a toxicologists opinion. CMR Workshop.
Litchfield JT (1962) Evaluation of the safety of new drugs by means of tests in animals. Clin Pharmacol Ther 3: 665-72.
Nimmo WS., Watson N (1994) What a clinical pharmacologist requires from toxicokinetic studies. Drug Inf J 28: 185-6.
Olson H, Betton G, Robinson D, Thomas K, Monro A, et al. (2000) Concordance of the toxicity of pharmaceuticals in humans and in animals. Regulat Toxicol Pharmacol 32: 56-67.
Orme M, Harry J, Routledge P, Hobson S (1989) Healthy volunteer studies in Great Britain: the results of a survey into 12 months activity in this field. Br J Clin Pharmacol 27: 125-33.
Parkinson C, McAuslane N, Lumley C, Walker SR (2000) The Timing of Toxicological Studies to Support Clinical Trials. Boston: Kluwer, pp. 67-74
Pharmaceutical Manufacturers Association (PMA) (1977) Pharmaceutical Manufacturers Association Guidelines for the Assessment of Drug and Medical Device Safety in Animals. Washington: PMA.
Sibille M, Deigat N, Olagnier V, Vital Durand D, Levrat R (1992) Adverse events in phase one studies: a study in 430 healthy volunteers. Eur J Clin Pharmacol 42: 389-93.
Wyld PJ (1991) Clinical pathology measurements: the detection and significance of what is abnormal. In: Nimmo WS, Tucker GT, eds, Clinical Measurement in Drug Evaluation. London: Wolfe, pp. 115 -25.
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