Bioequivalence and Bioavailability Forum • Canada: Draft Guidances published

Canada: Draft Guidances published [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2010-01-28 01:52 (5998 d 18:13 ago) – Posting: # 4652
Views: 8,432

Dear all,

on January 25 Health Canada published two draft guidances:

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. 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.
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.

The existing documents which will be superseded, once the two draft documents are finalized, are as follows:

Guidance for Industry: Conduct and Analysis of Bioavailability and Bioequivalence Studies - Part A: Oral Dosage Formulations Used for Systemic Effects (1992).
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).
Guidance for Industry: Conduct and Analysis of Bioavailability and Bioequivalence Studies - Part B: Oral Modified Release Formulations (1996).
Draft Policy: Bioequivalence Requirements: Drugs Exhibiting Non-Linear Pharmacokinetics (2003).
Notice to industry: Removal of Requirement for 15% Random Replicate Samples (2003).
Draft Guidance for Industry: Use of Metabolite Data in Comparative Bioavailability Studies (2004).
Notice to industry: Bioequivalence requirements for combination drug products (2004).
Guidance for Industry: Bioequivalence Requirements: Comparative Bioavailability Studies Conducted in the Fed State (2005).
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).
Notice to Industry: Bioequivalence Requirements for Long Half-life Drugs (2005).
Guidance for Industry: Bioequivalence Requirements: Critical Dose Drugs (2006).

Comments should be provided to Health Canada within 60 days of the publication of this Notice.

—
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Helmut Schütz

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Complete thread:

Canada: Draft Guidances publishedHelmut 2010-01-28 00:52 [Regulatives / Guidelines]
- Outlier earlybird 2010-02-09 08:35
  - Outlier (tests?) Helmut 2010-02-09 14:55
    - Outlier (tests?) earlybird 2010-02-09 16:45
      - Outlier (tests?) Helmut 2010-02-09 17:05
        
        Outlier (tests?) earlybird 2010-02-09 17:18
        Outlier "im Quadrat" d_labes 2010-02-10 13:51
        
        Hotelling's T² Helmut 2010-02-11 17:56
    - Lund! d_labes 2010-02-10 13:36
      - Lund! Helmut 2010-02-12 20:04
        
        intercept ElMaestro 2010-02-12 20:29
        
        intercept Helmut 2010-02-13 00:03
        
        intercept ElMaestro 2010-02-13 01:04
        
        Lund's critical values, technically d_labes 2010-02-22 12:52
        
        R code ElMaestro 2010-02-25 14:22
        
        R code quest d_labes 2010-02-25 16:34
        
        R code quest ElMaestro 2010-02-25 17:06