Bioequivalence and Bioavailability Forum

linear or nonlinear pharmacokinetics of lymecyclin [PK / PD]

posted by Dr_Dan – Germany, 2013-09-04 12:03 (4325 d 18:32 ago) – Posting: # 11428
Views: 6,786

Hi Mauricio
Lymecycline can not have linear Pk since it is not available in the systemic circulation. The active component of this prodrug tetracycline has linear Pk.
However, I still do not know why you want to test your 150 mg formulation against the 300 mg formulation of the originator. A 150 mg formulation would not be a generic and since a respective originator strength is missing you could only test 2×150 test against 1×300 reference. For a new 150 mg formulation you would also not only need PK data but also data for safety and efficacy.
Kind regards
Dan

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Kind regards and have a nice day
Dr_Dan

Complete thread:

linear or nonlinear pharmacokinetics of lymecyclin Mauricio Sampaio 2013-05-12 21:59
- linear or nonlinear pharmacokinetics of lymecyclin Dr_Dan 2013-05-13 09:39
  - linear or nonlinear pharmacokinetics of lymecyclin Mauricio Sampaio 2013-05-14 01:12
    - linear or nonlinear pharmacokinetics of lymecyclin Dr_Dan 2013-05-14 09:32
      - linear or nonlinear pharmacokinetics of lymecyclin Mauricio Sampaio 2013-09-04 00:04
        
        linear or nonlinear pharmacokinetics of lymecyclinDr_Dan 2013-09-04 10:03
        
        linear or nonlinear pharmacokinetics of lymecyclin Mauricio Sampaio 2013-09-07 01:18

linear or nonlinear pharmacokinetics of lyme­cyclin [PK / PD]

Complete thread:

linear or nonlinear pharmacokinetics of lymecyclin [PK / PD]