Draft Guidance for Industry: Preparation of Comparative Bioavailability Information for Drug Submissions in the CTD Format - Health Canada notice 2004-05-18

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Contact: Bureau of Pharmaceutical Sciences (BPS) Enquiries

Notice

May 18, 2004

Our file number: 04-110049-439

The June 25, 2003 draft version of this Health Canada (HC) guidance has been updated to reflect revisions resulting from comments received during the stakeholder consultation period.

This updated draft will immediately supersede the previous HC guidance documents, Guidance for Industry - Preparation of Bioequivalence Information of Drug Submissions in the CTD Format (September 12, 2001) and Preparation of Drug Submissions: Comparative Bioavailability Studies (October 8, 1997). Comments and suggestions received from the consultation on this updated draft version of the guidance will be reviewed and considered in the finalization of this document.

This guidance document supplements the ICH CTD: Efficacy (M4E) guidance and the HC Guidance for Industry - Preparation of New Drug Submissions in the CTD Format, two documents which together define placeholders for comparative bioavailability information. In addition, this guidance, in conjunction with the ICH Harmonised Tripartite Guideline - Structure and Content of Clinical Study Reports (E3), references some of the technical requirements related to the conduct and analysis of such studies.

Of note, although the creation of this document was intended to result in formatting changes only, two technical requirements were considered no longer necessary and as a result, were removed as a requirement. The pharmacokinetic variable file (suggested extension .pkv) and random replicate samples are no longer required and need not be submitted. The removal of this technical data takes precedence over existing HC guidances that currently reference them as requirements.

This document should be read in conjunction with this notice and with the relevant sections of other applicable Health Canada guidances.

This and other guidance documents are available on the Therapeutic Products Directorate/Biologics and Genetic Therapies Directorate Website(s). The availability of printed copies of guidance documents may be confirmed by consulting the Guidelines and Publications Order Forms (available on the TPD/BGTD Website) or by contacting the Publications Coordinator¹.

Comments should be submitted no later than July 25, 2004 and should be directed to:

Susan Stojdl
Assessment Officer
Bureau of Pharmaceutical Sciences
A/L 02301C
Therapeutic Products Directorate
Health Canada
1010 Somerset St. W.
Tunney's Pasture
Ottawa, Ontario
K1A 1B9

Internet: susan_stojdl@hc-sc.gc.ca

Phone: (613) 946-6989
Fax: (613) 941-8899

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¹ Tel: (613) 954-6466; E-mail: publications_coordinator@hc-sc.gc.ca