Ing. Helmut Schütz
Bioequivalence Requirements: Critical Dose Drugs
Canada – HPFB
On 31 May 2006 Canada’s HPFB published a ‘Guidance for Industry. Bioequivalence Requirements: Critical Dose Drugs’.
The category of ‘Critical Dose Drugs’ is intended to replace the categories of narrow therapeutic range drugs and highly toxic drugs defined in Report C of the Expert Advisory Committee on Bioavailability and Bioequivalence (1992).
The guidance includes additional clarification as a result of comments that have been received (where appropriate) as well as to promote consistency with other Health Canada guidance documents.
Appendix I of the guidance provides a list of critical dose drugs, namely: cyclosporine, digoxin, flecainide, lithium, phenytoin, sirolimus, tacrolimus, theophylline, and warfarin.
The guidance is effective with 31 May 2006.
Update
The guidance is superseded by two guidances issued on 22 May 2012:
document date 2006-12-08 | last update 2022-10-19