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luvblooms ★★ India, 2012-05-23 08:50 (5146 d 14:01 ago) Posting: # 8610 Views: 7,794 |
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Dear All Finally Health Canada has published the final BE guidance  for1. Conduct and Analysis of Comparative Bioavailability Studies 2. Comparative Bioavailability Standards: Formulations Used for Systemic Effects These guidance will be superseded by these guidances when they come into effect, are as follows: Guidance for Industry: Conduct and Analysis of Bioavailability and Bioequivalence Studies - Part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 Draft Guidance for Industry: Use of Metabolite Data in Comparative Bioavailability Studies (2004).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). These guidance documents will come into effect for submissions filed on or after July 1, 2012, with the following exceptions Where the requirements in these guidance documents are reduced relative to existing guidance, the reduced requirements will be effective immediately. Where the requirements in these guidance documents are increased relative to existing guidance, the increased requirements will only be applied to studies initiated on or after July 1, 2012. Regards Luv — ~A happy Soul~ |
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jag009 ★★★ NJ, 2012-05-23 18:11 (5146 d 04:40 ago) @ luvblooms Posting: # 8612 Views: 6,792 |
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Thanks ! So steady state BE study is generally not required for MR products. That is new... I had to run all three (Fast, Fed, SS) a few years back... John |
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Debbie ★ India, 2012-05-26 19:45 (5143 d 03:07 ago) @ luvblooms Posting: # 8619 Views: 6,920 |
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Hi, As per the section 2.1 of finalised Health Canada guidelines titled "Comparative Bioavailability Standards: Formulations Used for Systemic Effects (Effective Date: 2012/05/22)" In exceptional cases where a reference batch with a measured drug content differing less than 5% from the test product cannot be found, potency correction may be accepted. If potency correction is to be used, this intention should be pre-specified in the protocol and justified. The results from the potency assay of the test and reference products should be submitted. In such cases, the applicable bioequivalence standards should be met on both potency-corrected and uncorrected data. When the potency of test and reference products are differing by more than 10 to 15% (or even more), is it possible to meet the bioequivalence standards on both corrected and uncorrected data? Regards, |
Ing. Helmut Schütz