Ing. Helmut Schütz

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Canada – HPFB

Draft Guidance Documents

• Conduct and Analysis of Comparative Bioavailability Studies
• Comparative Bioavailability Standards: Formulations used for Systemic Effects

On 25 Jan 2010 Health Canada  published two drafted guidances for a 60 days public consultation period:
 Conduct and Analysis of Comparative Bioavailability Studies ( 190KB PDF)
 Comparative Bioavailability Standards: Formulations Used for Systemic Effects (58KB PDF)

The purpose of these documents is to update and consolidate eleven existing Health Canada documents related to the conduct and analysis of comparative bioavailability studies and the standards to be met in those studies in order to comply with Sections C.08.002(2)(h), C.08.002.1(2)(c)(ii) and C.08.003(3) of the Food and Drug Regulations. Please note, however, until such time as these guidances are finalized and published, current bioequivalence requirements remain unchanged and proposals in the draft guidances are not to be implemented.

Documents are being released for a 60-day comment period. Health Canada will review the comments received during this comment period and revise the Guidance as necessary. A final version of these documents will then be posted.

This consultation was open for comment starting January 25, 2010 until March 26, 2010. Please submit your comments via email, fax or by mail to:

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C5
Ottawa, Ontario
K1A 0K9
Telephone: 613-948-4623
Facsimile: 613-941-1812
E-mail: [email protected]

The existing documents which will be superseded, once the two draft documents are finalized, are as follows:

1. Guidance for Industry: Conduct and Analysis of Bioavailability and Bioequivalence Studies – Part A: Oral Dosage Formulations Used for Systemic Effects (1992)
2. Report C (of the Expert Advisory Committee on Bioavailability and Bioequivalence): Report on Bioavailability of Oral Dosage Formulations, Not in Modified Release Form, of Drugs Used for Systemic Effects, Having Complicated or Variable Pharmacokinetics (1992)
3. Guidance for Industry: Conduct and Analysis of Bioavailability and Bioequivalence Studies – Part B: Oral Modified Release Formulations (1996)
4. Draft Policy: Bioequivalence Requirements: Drugs Exhibiting Non-Linear Pharmacokinetics (2003)
5. Notice to industry: Removal of Requirement for 15% Random Replicate Samples (2003)
6. Draft Guidance for Industry: Use of Metabolite Data in Comparative Bioavailability Studies (2004)
7. Notice to industry: Bioequivalence requirements for combination drug products (2004)
8. Guidance for Industry: Bioequivalence Requirements: Comparative Bioavailability Studies Conducted in the Fed State (2005)
9. Notice to Industry: Bioequivalence Requirements for Drugs for Which an Early Time of Onset or Rapid Rate of Absorption Is Important (rapid onset drugs) (2005)
10. Notice to Industry: Bioequivalence Requirements for Long Half-life Drugs (2005)
11. Guidance for Industry: Bioequivalence Requirements: Critical Dose Drugs (2006)

Please note, however, that Section 2.6: Analytical Methodology in the draft document Conduct and Analysis of Comparative Bioavailability Studies, is currently still under revision and further consultation will be undertaken, as appropriate. Health Canada invites stakeholders to provide advance recommendations on analytical methodology, particularly assay validation. These recommendations will be taken into consideration in revising this section.

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Update

Final guidances were published on 22 May 2012. For details see here.