Bioequivalence and Bioavailability Forum • PK Parameters for Bioequivalent Criteria

PK Parameters for Bioequivalent Criteria [Regulatives / Guidelines]

posted by omprakash – India, 2017-01-23 13:21 (2649 d 08:15 ago) – Posting: # 16993
Views: 6,630

Dear Sir,

We have developed Paracetamol Sr 665mg tablets (Unilayer) versus Panadol 665mg tablets (bilayer, 31% IR + 69% SR).

Then what will be the primary PK parameters for Bio-equivalent criteria. Whether Cmax also compulsory to meet Bio-equivalent criteria then what will be the acceptance criteria. OR Only AUC is required as Bio-equivalent criteria?

Regards,

Om Prakash

Complete thread:

PK Parameters for Bioequivalent Criteriaomprakash 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 guideline Helmut 2017-02-04 18:25
        
        Australia’s = EMA’s MR guideline Muthu Raj 2017-02-06 12:01