Bioequivalence and Bioavailability Forum • Pharmacokinetics linearity

Pharmacokinetics linearity [Regulatives / Guidelines]

posted by pjs – India, 2015-05-28 18:11 (4046 d 15:12 ago) – Posting: # 14875
Views: 5,412

Dear nobody,

Apologies for the wrong terminology. What i mean to say was extrapolating the linearity on lower range. I also had doubts regarding this option as mentioned in my earlier post. But just wanted to know forum members view on that.

Apart from point 3 of earlier post would like to know view about the 1st and 2nd point of the forum members.

Has any body experinece in filling generic product in which similar extrapolation of the linearity has been done and accepted by the agency.

Thanks.

Regards,
PJS

Complete thread:

Pharmacokinetics linearity pjs 2015-05-20 10:25
- Pharmacokinetics linearity pjs 2015-05-28 12:26
  - Pharmacokinetics linearity nobody 2015-05-28 13:44
    - Pharmacokinetics linearity ElMaestro 2015-05-28 14:14
      - Pharmacokinetics linearity Dr_Dan 2015-05-28 14:32
        
        Pharmacokinetics linearity pjs 2015-05-28 14:58
        
        Pharmacokinetics linearity nobody 2015-05-28 15:50
        
        Pharmacokinetics linearitypjs 2015-05-28 16:11
        
        Pharmacokinetics linearity Dr_Dan 2015-05-29 09:03