This paper describes the current state of toxicokinetics in Canada from a regulator's viewpoint. The Canadian Health Protection Branch supports the use of toxicokinetics and believes that an integrated approach which combines toxicokinetic evaluations with selective well-conducted toxicological studies to establish the relationship between drug concentration and biological response is needed.
Drugs Directorate Guidelines, Toxicologic evaluation. Ontario, Canada: Health and Welfare Canada, Health Protection Branch; 1990.
2.
Drugs Directorate Guidelines, Conduct and analysis of bioavailability and bioequivalence studies. Part A. Ontario, Canada: Health and Welfare Canada, Health Protection Branch; 1992.
3.
Expert Advisory Committee on Bioavailability.Report B. Modified release dosage formulations. Ontario, Canada: Health Protection Branch; 1990.
4.
Drugs Directorate Guidelines, Preparation of human new drug submissions. Supplement. Ontario, Canada: Health and Welfare Canada, Health Protection Branch; December 1992.
5.
JordanA. FDA requirements for nonclinical testing of contraceptive steroids. Contraception. 1992;46: 499–509.
6.
BeaubienAR. New findings relate aminoglycoside ototoxicity to cumulative plasma or perilymph AUC. Inf Dis Newsletter. 1992;11(1):4–6.