Bioequivalence and Bioavailability Forum • Australia’s = EMA’s MR guideline

Australia’s = EMA’s MR guideline [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2017-02-04 19:25 (2631 d 17:33 ago) – Posting: # 17013
Views: 5,530

Hi Muthu Raj,

❝ The European Union guidelines adopted in Australia

❝ Primary PK Parameter: AUC_0-t and C_max

❝ Secondary PK Parameter: T_max

Here you err. Om Prakash is dealing with a modified-release product. Hence, the respective guideline should be observed (as mentioned by Dan above).

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Complete thread:

PK Parameters for Bioequivalent Criteria omprakash 2017-01-23 12:21 [Regulatives / Guidelines]
- PK Parameters for Bioequivalent Criteria Dr_Dan 2017-01-23 13:32
  - PK Parameters for Bioequivalent Criteria omprakash 2017-01-28 07:17
    - PK Parameters for Bioequivalent Criteria Muthu Raj 2017-02-04 12:58
      - Australia’s = EMA’s MR guidelineHelmut 2017-02-04 18:25
        
        Australia’s = EMA’s MR guideline Muthu Raj 2017-02-06 12:01