Bioequivalence and Bioavailability Forum • Statistics in multiple dose study

Statistics in multiple dose study [NCA / SHAM]

posted by ratnakar1811 – India, 2009-12-01 12:09 (5619 d 17:07 ago) – Posting: # 4402
Views: 14,011

Dear Forum Members,

We are planning a multiple dose crossover Bioequivalence study of Nasal Spray, wherein TID dose (08:00, 16:00 and 24:00 hrs) will be given for 4 days i.e. on 4th day after 08:00 hrs, profiling for PK will be done and pre-dose sample will be collected prior to the first dose of the study (1st dose of the study.

Now my query is that do we need to take blood samples till 5 half life of the drug and pre-dose sample also require to be taken prior to 4th day dosing? If we following parameters to be considered for BE
Parameters to be calculated:
Cmax
AUCtau
Tmax
Kel
and t1/2

Bioequivalence to be concluded if the Cmax and AUCtau are within 80-125%.

Your views/guidance will be highly appreciated in this regard.

Best Regards,

Ratnakar

Edit: Category changed. [Helmut]

Complete thread:

Statistics in multiple dose studyratnakar1811 2009-12-01 11:09 [NCA / SHAM]
- Statistics in multiple dose study Helmut 2009-12-02 00:20
  - Statistics in multiple dose study ratnakar1811 2009-12-03 07:36
    - Statistics in multiple dose study Helmut 2009-12-03 14:53
      - Statistics in multiple dose study ratnakar1811 2009-12-04 08:21
  - Metrics for multiple profiles d_labes 2009-12-03 08:58
    - Metrics for multiple profiles Helmut 2009-12-03 15:50
      - Metrics for multiple profiles d_labes 2009-12-03 16:02
        
        Metrics for multiple profiles Helmut 2009-12-03 16:11
      - PTF is another story d_labes 2009-12-03 16:17
        
        PTF is another story Helmut 2009-12-03 16:42
        
        the flatter is better? d_labes 2009-12-04 08:46
        
        Biopharmaceutical history Helmut 2009-12-04 12:35