BEBAC   Ing. Helmut Schütz

Canada – HPFB

Comparative Bioavailability: Guidances

On 22 May 2012 Health Canada published two final guidances which came into effect for submissions filed on or after July 1, 2012:

With respect to bioanalytical method validation and analysis of study samples, these guidance documents now make reference to the principles and procedures described in the European Medicines Agency Guideline on bioanalytical method validation.

Following documents are superseded by these guidances:

  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 Draft Guidance for Industry: Use of Metabolite Data in Comparative Bioavailability Studies (2004)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)
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